Trial Outcomes & Findings for Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS) (NCT NCT05408975)
NCT ID: NCT05408975
Last Updated: 2026-02-02
Results Overview
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.
COMPLETED
NA
5 participants
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
2026-02-02
Participant Flow
Participant milestones
| Measure |
Active to Sham Transcranial Direct Current Stimulation
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
Sham to Active Transcranial Direct Current Stimulation
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects were assigned to active stimulation.
|
|---|---|---|
|
Baseline
STARTED
|
3
|
2
|
|
Baseline
COMPLETED
|
3
|
2
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Immediately Post Phase 1 Intervention
STARTED
|
3
|
2
|
|
Immediately Post Phase 1 Intervention
COMPLETED
|
3
|
2
|
|
Immediately Post Phase 1 Intervention
NOT COMPLETED
|
0
|
0
|
|
8 Weeks Post Phase 1 Intervention
STARTED
|
3
|
2
|
|
8 Weeks Post Phase 1 Intervention
COMPLETED
|
3
|
2
|
|
8 Weeks Post Phase 1 Intervention
NOT COMPLETED
|
0
|
0
|
|
Immediately Post Phase 2 Intervention
STARTED
|
3
|
2
|
|
Immediately Post Phase 2 Intervention
COMPLETED
|
2
|
2
|
|
Immediately Post Phase 2 Intervention
NOT COMPLETED
|
1
|
0
|
|
8 Weeks Post Phase 2 Intervention
STARTED
|
2
|
2
|
|
8 Weeks Post Phase 2 Intervention
COMPLETED
|
2
|
2
|
|
8 Weeks Post Phase 2 Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
Baseline characteristics by cohort
| Measure |
Active to Sham Transcranial Direct Current Stimulation
n=3 Participants
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
|
Sham to Active Transcranial Direct Current Stimulation
n=2 Participants
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 24.6 • n=41 Participants
|
50 years
STANDARD_DEVIATION 15.6 • n=1581 Participants
|
48.6 years
STANDARD_DEVIATION 19.1 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
The Controlled Oral Word Association Test
|
30.67 items
STANDARD_DEVIATION 7.23 • n=41 Participants
|
30.5 items
STANDARD_DEVIATION 0.71 • n=1581 Participants
|
30.6 items
STANDARD_DEVIATION 5.13 • n=4626 Participants
|
|
Category Fluency
|
18 Total items
STANDARD_DEVIATION 1.73 • n=41 Participants
|
17 Total items
STANDARD_DEVIATION 0 • n=1581 Participants
|
17.6 Total items
STANDARD_DEVIATION 1.34 • n=4626 Participants
|
|
The Boston Naming Test
|
26.67 Total items
STANDARD_DEVIATION 2.52 • n=41 Participants
|
28 Total items
STANDARD_DEVIATION 0 • n=1581 Participants
|
27.2 Total items
STANDARD_DEVIATION 1.93 • n=4626 Participants
|
|
Semantic Object Retrieval Test
|
30.33 Total items
STANDARD_DEVIATION 1.53 • n=41 Participants
|
30.5 Total items
STANDARD_DEVIATION 2.12 • n=1581 Participants
|
30.4 Total items
STANDARD_DEVIATION 1.52 • n=4626 Participants
|
|
The Delis Kaplan Color Word Interference Test, naming
|
35.66666667 Time- Seconds
STANDARD_DEVIATION 5.131601439 • n=41 Participants
|
41 Time- Seconds
STANDARD_DEVIATION 7.071067812 • n=1581 Participants
|
37.8 Time- Seconds
STANDARD_DEVIATION 5.85 • n=4626 Participants
|
|
The Delis Kaplan Color Word Interference Test, reading
|
26 Time - seconds
STANDARD_DEVIATION 6.244997998 • n=41 Participants
|
27.5 Time - seconds
STANDARD_DEVIATION 12.02081528 • n=1581 Participants
|
26.6 Time - seconds
STANDARD_DEVIATION 7.503332593 • n=4626 Participants
|
|
The Delis Kaplan Color Word Interference Test, inhibition
|
57 Time - seconds
STANDARD_DEVIATION 5 • n=41 Participants
|
71.5 Time - seconds
STANDARD_DEVIATION 9.192388155 • n=1581 Participants
|
62.8 Time - seconds
STANDARD_DEVIATION 9.833615815 • n=4626 Participants
|
|
The Delis Kaplan Color Word Interference Test, inhibition and switching
|
71.33333333 Time - seconds
STANDARD_DEVIATION 19.85782801 • n=41 Participants
|
75 Time - seconds
STANDARD_DEVIATION 16.97056275 • n=1581 Participants
|
72.8 Time - seconds
STANDARD_DEVIATION 16.52876281 • n=4626 Participants
|
|
Rey Auditory Verbal Learning Test and alternative lists, total learning
|
40.66666667 Total items
STANDARD_DEVIATION 15.14375559 • n=41 Participants
|
48.5 Total items
STANDARD_DEVIATION 3.535533906 • n=1581 Participants
|
43.8 Total items
STANDARD_DEVIATION 11.67047557 • n=4626 Participants
|
|
Rey Auditory Verbal Learning Test and alternative lists, delayed recall
|
7.333333333 Total items
STANDARD_DEVIATION 5.033222957 • n=41 Participants
|
9.5 Total items
STANDARD_DEVIATION 0.707106781 • n=1581 Participants
|
8.2 Total items
STANDARD_DEVIATION 3.768288736 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2.
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Controlled Oral Word Association Test
Immediate post completion of phase 1 intervention
|
35 Total items
Standard Deviation 0
|
33.33 Total items
Standard Deviation 5.69
|
|
The Controlled Oral Word Association Test
Baseline
|
30.5 Total items
Standard Deviation 0.71
|
30.67 Total items
Standard Deviation 7.23
|
|
The Controlled Oral Word Association Test
8 weeks post completion of phase 1 intervention
|
39.5 Total items
Standard Deviation 7.78
|
34.67 Total items
Standard Deviation 7.51
|
|
The Controlled Oral Word Association Test
Immediate post completion of phase 2 intervention
|
48.5 Total items
Standard Deviation 3.54
|
31 Total items
Standard Deviation 9.9
|
|
The Controlled Oral Word Association Test
8 weeks post completion of phase 2 intervention
|
43.5 Total items
Standard Deviation 4.95
|
33.5 Total items
Standard Deviation 4.95
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2.
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Category Fluency
Baseline
|
17 Total items
Standard Deviation 0
|
18 Total items
Standard Deviation 1.73
|
|
Category Fluency
Immediate post completion of phase 1 intervention
|
24.5 Total items
Standard Deviation 0.71
|
17.67 Total items
Standard Deviation 6.35
|
|
Category Fluency
8 weeks post completion of phase 1 intervention
|
22.5 Total items
Standard Deviation 0.71
|
20 Total items
Standard Deviation 2.65
|
|
Category Fluency
Immediate post completion of phase 2 intervention
|
27.5 Total items
Standard Deviation 3.54
|
11 Total items
Standard Deviation 1.41
|
|
Category Fluency
8 weeks post completion of phase 2 intervention
|
20.5 Total items
Standard Deviation 0.71
|
17.5 Total items
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Boston Naming Test
Baseline
|
28 Total items
Standard Deviation 0
|
26.67 Total items
Standard Deviation 2.52
|
|
The Boston Naming Test
Immediate post completion of phase 1 intervention
|
29.5 Total items
Standard Deviation 0.71
|
27 Total items
Standard Deviation 1
|
|
The Boston Naming Test
8 weeks post completion of phase 1 intervention
|
28.5 Total items
Standard Deviation 2.12
|
27.33 Total items
Standard Deviation 1.53
|
|
The Boston Naming Test
Immediate post completion of phase 2 intervention
|
30 Total items
Standard Deviation NA
Only one subject
|
27 Total items
Standard Deviation 1.41
|
|
The Boston Naming Test
8 weeks post completion of phase 2 intervention
|
30 Total items
Standard Deviation 0
|
28 Total items
Standard Deviation 2.83
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Semantic Object Retrieval Test
Baseline
|
30.5 Total items
Standard Deviation 2.12
|
30.33 Total items
Standard Deviation 1.53
|
|
Semantic Object Retrieval Test
Immediate post completion of phase 1 intervention
|
31.5 Total items
Standard Deviation 0.71
|
31.33 Total items
Standard Deviation 1.15
|
|
Semantic Object Retrieval Test
8 weeks post completion of phase 1 intervention
|
31 Total items
Standard Deviation 1.41
|
30.67 Total items
Standard Deviation 1.15
|
|
Semantic Object Retrieval Test
Immediate post completion of phase 2 intervention
|
31 Total items
Standard Deviation NA
Only one subject
|
30 Total items
Standard Deviation 1.41
|
|
Semantic Object Retrieval Test
8 weeks post completion of phase 2 intervention
|
31.5 Total items
Standard Deviation 0.71
|
32 Total items
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Naming
Baseline
|
41 Time - seconds
Standard Deviation 7.071067812
|
35.66666667 Time - seconds
Standard Deviation 5.131601439
|
|
The Delis Kaplan Color Word Interference Test, Naming
Immediate post completion of phase 1 intervention
|
31 Time - seconds
Standard Deviation 8.485281374
|
32.66666667 Time - seconds
Standard Deviation 2.516611478
|
|
The Delis Kaplan Color Word Interference Test, Naming
8 weeks post completion of phase 1 intervention
|
34.5 Time - seconds
Standard Deviation 7.778174593
|
31.66666667 Time - seconds
Standard Deviation 4.509249753
|
|
The Delis Kaplan Color Word Interference Test, Naming
Immediate post completion of phase 2 intervention
|
32 Time - seconds
Standard Deviation NA
Only one subject
|
34.5 Time - seconds
Standard Deviation 3.535533906
|
|
The Delis Kaplan Color Word Interference Test, Naming
8 weeks post completion of phase 2 intervention
|
34.5 Time - seconds
Standard Deviation 3.535533906
|
29 Time - seconds
Standard Deviation 5.656854249
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Reading
Baseline
|
27.5 Time - seconds
Standard Deviation 12.02081528
|
26 Time - seconds
Standard Deviation 6.244997998
|
|
The Delis Kaplan Color Word Interference Test, Reading
Immediate post completion of phase 1 intervention
|
24 Time - seconds
Standard Deviation 4.242640687
|
24 Time - seconds
Standard Deviation 7
|
|
The Delis Kaplan Color Word Interference Test, Reading
8 weeks post completion of phase 1 intervention
|
25.5 Time - seconds
Standard Deviation 7.778174593
|
25.66666667 Time - seconds
Standard Deviation 6.658328118
|
|
The Delis Kaplan Color Word Interference Test, Reading
Immediate post completion of phase 2 intervention
|
27 Time - seconds
Standard Deviation NA
Only one subject
|
31.5 Time - seconds
Standard Deviation 3.535533906
|
|
The Delis Kaplan Color Word Interference Test, Reading
8 weeks post completion of phase 2 intervention
|
27 Time - seconds
Standard Deviation 4.242640687
|
24.5 Time - seconds
Standard Deviation 0.707106781
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Baseline
|
71.5 Time - seconds
Standard Deviation 9.192388155
|
57 Time - seconds
Standard Deviation 5
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Immediate post completion of phase 1 intervention
|
64 Time - seconds
Standard Deviation 9.899494937
|
46 Time - seconds
Standard Deviation 2.645751311
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
8 weeks post completion of phase 1 intervention
|
58.5 Time - seconds
Standard Deviation 9.192388155
|
53 Time - seconds
Standard Deviation 3.464101615
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
Immediate post completion of phase 2 intervention
|
66 Time - seconds
Standard Deviation NA
Only one subject
|
48 Time - seconds
Standard Deviation 5.656854249
|
|
The Delis Kaplan Color Word Interference Test, Inhibition
8 weeks post completion of phase 2 intervention
|
59.5 Time - seconds
Standard Deviation 2.121320344
|
46.5 Time - seconds
Standard Deviation 0.707106781
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Baseline
|
75 Time - seconds
Standard Deviation 16.97056275
|
71.33333333 Time - seconds
Standard Deviation 19.85782801
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Immediate post completion of phase 1 intervention
|
58 Time - seconds
Standard Deviation 8.485281374
|
72 Time - seconds
Standard Deviation 29.13760457
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
8 weeks post completion of phase 1 intervention
|
56.5 Time - seconds
Standard Deviation 6.363961031
|
75.33333333 Time - seconds
Standard Deviation 24.19366308
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
Immediate post completion of phase 2 intervention
|
53 Time - seconds
Standard Deviation NA
Only one subject
|
61.5 Time - seconds
Standard Deviation 3.535533906
|
|
The Delis Kaplan Color Word Interference Test, Inhibition and Switching
8 weeks post completion of phase 2 intervention
|
52 Time - seconds
Standard Deviation 0
|
70 Time - seconds
Standard Deviation 9.899494937
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Baseline
|
48.5 Total items
Standard Deviation 3.535533906
|
40.66666667 Total items
Standard Deviation 15.14375559
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Immediate post completion of phase 1 intervention
|
57 Total items
Standard Deviation 7.071067812
|
39.33333333 Total items
Standard Deviation 11.8462371
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
8 weeks post completion of phase 1 intervention
|
58 Total items
Standard Deviation 4.242640687
|
43.66666667 Total items
Standard Deviation 11.59022577
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
Immediate post completion of phase 2 intervention
|
73 Total items
Standard Deviation NA
Only one subject
|
40.5 Total items
Standard Deviation 17.67766953
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning
8 weeks post completion of phase 2 intervention
|
63 Total items
Standard Deviation 7.071067812
|
38.5 Total items
Standard Deviation 3.535533906
|
PRIMARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Baseline
|
9.5 Total items
Standard Deviation 0.707106781
|
7.333333333 Total items
Standard Deviation 5.033222957
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Immediate post completion of phase 1 intervention
|
12 Total items
Standard Deviation 1.414213562
|
6 Total items
Standard Deviation 4.582575695
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
8 weeks post completion of phase 1 intervention
|
13.5 Total items
Standard Deviation 2.121320344
|
8.666666667 Total items
Standard Deviation 4.509249753
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
Immediate post completion of phase 2 intervention
|
15 Total items
Standard Deviation NA
Only one subject
|
7.5 Total items
Standard Deviation 6.363961031
|
|
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall
8 weeks post completion of phase 2 intervention
|
11.5 Total items
Standard Deviation 3.535533906
|
7 Total items
Standard Deviation 1.414213562
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Trail Making Test - Part A
Baseline
|
41.5 Time - seconds
Standard Deviation 7.778174593
|
37.66666667 Time - seconds
Standard Deviation 14.36430762
|
|
The Trail Making Test - Part A
Immediate post completion of phase 1 intervention
|
26.5 Time - seconds
Standard Deviation 13.43502884
|
27.66666667 Time - seconds
Standard Deviation 11.93035345
|
|
The Trail Making Test - Part A
8 weeks post completion of phase 1 intervention
|
27 Time - seconds
Standard Deviation 5.656854249
|
28 Time - seconds
Standard Deviation 19.28730152
|
|
The Trail Making Test - Part A
Immediate post completion of phase 2 intervention
|
29 Time - seconds
Standard Deviation NA
Only one subject
|
30.5 Time - seconds
Standard Deviation 14.8492424
|
|
The Trail Making Test - Part A
8 weeks post completion of phase 2 intervention
|
26.5 Time - seconds
Standard Deviation 9.192388155
|
34.5 Time - seconds
Standard Deviation 26.1629509
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Trail Making Test - Part B
8 weeks post completion of phase 1 intervention
|
63.5 Time - seconds
Standard Deviation 7.778174593
|
57.66666667 Time - seconds
Standard Deviation 21.22105872
|
|
The Trail Making Test - Part B
Immediate post completion of phase 2 intervention
|
62 Time - seconds
Standard Deviation NA
Only one subject
|
61.5 Time - seconds
Standard Deviation 10.60660172
|
|
The Trail Making Test - Part B
8 weeks post completion of phase 2 intervention
|
71.5 Time - seconds
Standard Deviation 7.778174593
|
58 Time - seconds
Standard Deviation 15.55634919
|
|
The Trail Making Test - Part B
Baseline
|
101 Time - seconds
Standard Deviation 9.899494937
|
68.66666667 Time - seconds
Standard Deviation 21.57158625
|
|
The Trail Making Test - Part B
Immediate post completion of phase 1 intervention
|
52.5 Time - seconds
Standard Deviation 16.26345597
|
63.66666667 Time - seconds
Standard Deviation 3.511884584
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Digit Span Forward
Baseline
|
0.4 Units on Z scale
Standard Deviation 0.707106781
|
0.933333333 Units on Z scale
Standard Deviation 1.078579312
|
|
Digit Span Forward
Immediate post completion of phase 1 intervention
|
-0.085 Units on Z scale
Standard Deviation 0.021213203
|
0.3 Units on Z scale
Standard Deviation 0.556776436
|
|
Digit Span Forward
8 weeks post completion of phase 1 intervention
|
-0.1 Units on Z scale
Standard Deviation 0
|
-0.34 Units on Z scale
Standard Deviation 0.819023809
|
|
Digit Span Forward
Immediate post completion of phase 2 intervention
|
-1.05 Units on Z scale
Standard Deviation NA
Only one subject
|
0.05 Units on Z scale
Standard Deviation 0.494974747
|
|
Digit Span Forward
8 weeks post completion of phase 2 intervention
|
-0.575 Units on Z scale
Standard Deviation 0.671751442
|
-0.85 Units on Z scale
Standard Deviation 0.777817459
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Digit Span Backward
Baseline
|
0.7 Units on Z scale
Standard Deviation 1.272792206
|
0.2 Units on Z scale
Standard Deviation 1.252996409
|
|
Digit Span Backward
Immediate post completion of phase 1 intervention
|
1.525 Units on Z scale
Standard Deviation 0.035355339
|
-0.933333333 Units on Z scale
Standard Deviation 0.56862407
|
|
Digit Span Backward
8 weeks post completion of phase 1 intervention
|
0.25 Units on Z scale
Standard Deviation 0.636396103
|
0.44 Units on Z scale
Standard Deviation 0.991362699
|
|
Digit Span Backward
Immediate post completion of phase 2 intervention
|
-0.19 Units on Z scale
Standard Deviation NA
Only one subject
|
0.81 Units on Z scale
Standard Deviation 1.965756852
|
|
Digit Span Backward
8 weeks post completion of phase 2 intervention
|
0.68 Units on Z scale
Standard Deviation 0.028284271
|
0.385 Units on Z scale
Standard Deviation 2.566797616
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Baseline
|
25.5 Score on a scale
Standard Deviation 2.121320344
|
15.16666667 Score on a scale
Standard Deviation 0.577350269
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Immediate post completion of phase 1 intervention
|
28 Score on a scale
Standard Deviation 9.899494937
|
18.5 Score on a scale
Standard Deviation 3.905124838
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
8 weeks post completion of phase 1 intervention
|
32.5 Score on a scale
Standard Deviation 0.707106781
|
18 Score on a scale
Standard Deviation 5.408326913
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
Immediate post completion of phase 2 intervention
|
31 Score on a scale
Standard Deviation NA
Only one subject
|
14 Score on a scale
Standard Deviation 9.899494937
|
|
Rey-Osterrieth Complex Figure Test - Delayed Recall
8 weeks post completion of phase 2 intervention
|
25.45 Score on a scale
Standard Deviation 3.606244584
|
24 Score on a scale
Standard Deviation 11.3137085
|
SECONDARY outcome
Timeframe: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.Population: n=3 assigned to Active to Sham arm completed phase 1 (Baseline, Immediately post phase 1 intervention, 8 weeks after post phase 1 intervention), and only n=2 assigned to Active to Sham arm completed phase 2 (Immediately post phase 2 intervention, 8 weeks after post phase 2 intervention). n=2 assigned to Sham to Active completed both phases 1 \&2, except for one subject in the Sham to Active group missed data at the immediate post time point for phase 2.
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.
Outcome measures
| Measure |
Sham to Active
n=2 Participants
Subjects in this arm were first randomly assigned to receive sham stimulation. After completion of active stimulation, subjects were assigned to active stimulation.
|
Active to Sham
n=3 Participants
Subjects in this arm were first randomly assigned to receive active stimulation. After completion of active stimulation, subjects were assigned to sham stimulation.
|
|---|---|---|
|
The Digit Symbol Substitution Test
Immediate post completion of phase 2 intervention
|
53 Total items
Standard Deviation NA
Only one subject
|
50 Total items
Standard Deviation 4.242640687
|
|
The Digit Symbol Substitution Test
Baseline
|
45.5 Total items
Standard Deviation 14.8492424
|
45 Total items
Standard Deviation 5.196152423
|
|
The Digit Symbol Substitution Test
Immediate post completion of phase 1 intervention
|
58 Total items
Standard Deviation 11.3137085
|
45.33333333 Total items
Standard Deviation 2.516611478
|
|
The Digit Symbol Substitution Test
8 weeks post completion of phase 1 intervention
|
58.5 Total items
Standard Deviation 23.33452378
|
47.66666667 Total items
Standard Deviation 1.527525232
|
|
The Digit Symbol Substitution Test
8 weeks post completion of phase 2 intervention
|
62.5 Total items
Standard Deviation 9.192388155
|
48 Total items
Standard Deviation 4.242640687
|
Adverse Events
Active to Sham Transcranial Direct Current Stimulation
Sham to Active Transcranial Direct Current Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place