Trial Outcomes & Findings for Combining tDCS and CILT in Non-fluent Aphasia (NCT NCT05561400)
NCT ID: NCT05561400
Last Updated: 2025-12-09
Results Overview
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
COMPLETED
NA
10 participants
Baseline 1: occurred at Visit 2 (after consent)
2025-12-09
Participant Flow
Participant milestones
| Measure |
Real tDCS First
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS First
The participant receives the sham tDCS condition first and then crosses over to the real tDCS condition.
Sham tDCS: participant receives sham/placebo stimulation to the right cerebellum during behavioral intervention (CILT)
Participant is still fit wth 5x5cm saline soaked electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at "sham" condition which ramps up for \~60 seconds of stimulation before ramping down.
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|---|---|---|
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Overall Study
STARTED
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3
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2
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Overall Study
COMPLETED
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3
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2
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining tDCS and CILT in Non-fluent Aphasia
Baseline characteristics by cohort
| Measure |
Real tDCS First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS First
n=2 Participants
The participant receives the sham tDCS condition first and then crosses over to the real tDCS condition.
Sham tDCS: participant receives sham/placebo stimulation to the right cerebellum during behavioral intervention (CILT)
Participant is still fit wth 5x5cm saline soaked electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at "sham" condition which ramps up for \~60 seconds of stimulation before ramping down.
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Total
n=5 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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62 years
STANDARD_DEVIATION 8 • n=9 Participants
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61 years
STANDARD_DEVIATION 5.65 • n=6 Participants
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61.6 years
STANDARD_DEVIATION 6.35 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
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3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline 1: occurred at Visit 2 (after consent)Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse: Picture Description
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10 score on a scale
Standard Deviation 2.82
|
5.66 score on a scale
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: Follow up 1: Visit 9. 2 weeks after Baseline 1Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse Analysis: Picture Description
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7.66 Raw Score/Points
Standard Deviation 8.02
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13 Raw Score/Points
Standard Deviation 1.41
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PRIMARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse: Picture Description
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7 score on a scale
Standard Deviation 6.08
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14 score on a scale
Standard Deviation 8.48
|
PRIMARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Discourse Analysis: Picture Description
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11.66 score on a scale
Standard Deviation 10.40
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10 score on a scale
Standard Deviation 2.82
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PRIMARY outcome
Timeframe: Baseline 1: occurred at Visit 2Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse Analysis: Story Retell
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31 score on a scale
Standard Deviation 29.61
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23 score on a scale
Standard Deviation 7.07
|
PRIMARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Discourse Analysis: Story Retell
|
31.66 score on a scale
Standard Deviation 29.73
|
31 score on a scale
Standard Deviation 25.45
|
PRIMARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Discourse Analysis: Story Retell
|
33.66 score on a scale
Standard Deviation 30.66
|
28.5 score on a scale
Standard Deviation 14.84
|
PRIMARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse Analysis: Story Retell
|
35 score on a scale
Standard Deviation 30.41
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26 score on a scale
Standard Deviation 16.97
|
PRIMARY outcome
Timeframe: Baseline 1: Visit 2Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Discourse Analysis: Procedural
|
10 Raw Score/Points
Standard Deviation 9.53
|
17 Raw Score/Points
Standard Deviation 7.07
|
PRIMARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Discourse Analysis: Procedural
|
11.66 score on a scale
Standard Deviation 10.40
|
14 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Discourse Analysis: Procedural
|
14.33 score on a scale
Standard Deviation 9.29
|
15 score on a scale
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Discourse Analysis: Procedural
|
11.66 score on a scale
Standard Deviation 10.11
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14.5 score on a scale
Standard Deviation 3.53
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PRIMARY outcome
Timeframe: Baseline 1: Visit 2Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17 items. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Verbal Fluency: Semantic
|
12.33 raw score number of items named
Standard Deviation 12.01
|
18.5 raw score number of items named
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Verbal Fluency: Semantic
|
15.33 raw score number of items named
Standard Deviation 13.31
|
17.5 raw score number of items named
Standard Deviation 6.36
|
PRIMARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Verbal Fluency: Semantic
|
10.66 raw score number of items named
Standard Deviation 11.01
|
16 raw score number of items named
Standard Deviation 9.89
|
PRIMARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Verbal Fluency: Semantic
|
12 raw score number of items named
Standard Deviation 10.81
|
16 raw score number of items named
Standard Deviation 12.72
|
PRIMARY outcome
Timeframe: Baseline 1: Visit 2Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
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Verbal Fluency: Phonemic
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4.66 raw score number of items named
Standard Deviation 2.51
|
8.5 raw score number of items named
Standard Deviation 4.94
|
PRIMARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Verbal Fluency: Phonemic
|
4 raw score number of items named
Standard Deviation 3.6
|
14.5 raw score number of items named
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
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Verbal Fluency: Phonemic
|
3 raw score number of items named
Standard Deviation 2.64
|
12.5 raw score number of items named
Standard Deviation 13.43
|
PRIMARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is \>17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Verbal Fluency: Phonemic
|
4 raw score number of items named
Standard Deviation 4
|
18.5 raw score number of items named
Standard Deviation 13.43
|
SECONDARY outcome
Timeframe: Baseline 1: Visit 2To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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|---|---|---|
|
Working Memory
|
55.33 percentage of accuracy
Standard Deviation 20.52
|
70 percentage of accuracy
Standard Deviation 18.34
|
SECONDARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%.A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Working Memory
|
81.66 percentage of accuracy
Standard Deviation 16.07
|
71.5 percentage of accuracy
Standard Deviation 40.30
|
SECONDARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Working Memory
|
74.33 percentage of accuracy
Standard Deviation 22.89
|
76.5 percentage of accuracy
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Working Memory
|
77.33 percentage of accuracy
Standard Deviation 11.84
|
75 percentage of accuracy
Standard Deviation 35.35
|
SECONDARY outcome
Timeframe: Baseline 1: Visit 2Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. 3 subscales: Physical, the total number of questions is 16, minimum score is 16 and the maximum score is 80. Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5 Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Stroke Aphasia Quality of Life (SA-QOL)
|
3.74 score on a scale
Standard Deviation 0.313
|
3.37 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Follow up 1: Visit 9: 2 weeks after Baseline 1Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. 3 subscales: Physical, total number of questions is 16, minimum score is 16 and the maximum score is 80. Communication, total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Stroke Aphasia Quality of Life (SA-QOL)
|
3.74 score on a scale
Standard Deviation 0.27
|
3.77 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. There are 3 subscales: Physical, total number of questions is 16, minimum score is 16 and the maximum score is 80. Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
|
Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
|
|---|---|---|
|
Stroke Aphasia Quality of Life (SA-QOL)
|
4.00 score on a scale
Standard Deviation 0.69
|
3.81 score on a scale
Standard Deviation 0.707
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SECONDARY outcome
Timeframe: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. There are 3 subscales: Physical, the total number of questions is 16, minimum score is 16 and the maximum score is 80. Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Outcome measures
| Measure |
Real tDCS Condition First
n=3 Participants
The participant receives the real tDCS condition and then crosses over to the sham condition.
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
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Sham tDCS Condition First
n=2 Participants
The participant receives the sham tDCS condition and then crosses over to the real condition.
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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Stroke Aphasia Quality of Life (SA-QOL)
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4.15 score on a scale
Standard Deviation 0.64
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3.75 score on a scale
Standard Deviation 0.94
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Adverse Events
Real tDCS Condition
Sham tDCS Condition
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Real tDCS Condition
n=5 participants at risk
Real tDCS condition: paricipant received real tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes.
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Sham tDCS Condition
n=5 participants at risk
Sham condition: paricipant received sham tDCS to the right cerebellum at 2mA for 20 minutes during behavioral intervention (CILT)
Sham tDCS: 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the cathode placed on the right deltoid. tDCS was set at 2mA for 20 minutes. tDCS set at "sham" mode Sham is the placebo
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General disorders
Headache
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20.0%
1/5 • Number of events 3 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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20.0%
1/5 • Number of events 6 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
Neck Pain
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0.00%
0/5 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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20.0%
1/5 • Number of events 1 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
Tingling sensation
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60.0%
3/5 • Number of events 10 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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0.00%
0/5 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
Itching
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40.0%
2/5 • Number of events 3 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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0.00%
0/5 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
Burning sensation
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20.0%
1/5 • Number of events 1 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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0.00%
0/5 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
skin redness
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20.0%
1/5 • Number of events 6 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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20.0%
1/5 • Number of events 1 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
sleepiness
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40.0%
2/5 • Number of events 3 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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20.0%
1/5 • Number of events 2 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
Trouble concentrating
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40.0%
2/5 • Number of events 5 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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40.0%
2/5 • Number of events 4 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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General disorders
acute change of mood
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40.0%
2/5 • Number of events 3 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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40.0%
2/5 • Number of events 2 • Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.
The standard adverse events reported when using tDCS include: headache, neck pain, scalp pain, tigling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood. Adverse events were reported following each intervention session (12 in total). Partcipants were monitored for adverse effects through the course of the study (2 weeks during one condition and then 2 weeks during the second condition). Adverse events monitoring was not done during the wash out period.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place