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Trial Outcomes & Findings for Improving Aphasia Using Electrical Brain Stimulation (NCT NCT04963803)

NCT ID: NCT04963803

Last Updated: 2026-01-30

Results Overview

Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

Results posted on

2026-01-30

Participant Flow

Participant milestones

Participant milestones
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Overall Study
STARTED
12
11
Overall Study
COMPLETED
11
11
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

Improving Aphasia Using Electrical Brain Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Total
n=22 Participants
Total of all reporting groups
Age, Continuous
65 years
STANDARD_DEVIATION 7 • n=41 Participants
63 years
STANDARD_DEVIATION 12 • n=1581 Participants
64 years
STANDARD_DEVIATION 10 • n=4626 Participants
Sex: Female, Male
Female
2 Participants
n=41 Participants
6 Participants
n=1581 Participants
8 Participants
n=4626 Participants
Sex: Female, Male
Male
9 Participants
n=41 Participants
5 Participants
n=1581 Participants
14 Participants
n=4626 Participants
Western Aphasia Battery-Revised
80 Raw score
STANDARD_DEVIATION 20 • n=41 Participants
64 Raw score
STANDARD_DEVIATION 29 • n=1581 Participants
72 Raw score
STANDARD_DEVIATION 26 • n=4626 Participants
Race/Ethnicity, Customized
White
9 Participants
n=41 Participants
10 Participants
n=1581 Participants
19 Participants
n=4626 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=41 Participants
1 Participants
n=1581 Participants
3 Participants
n=4626 Participants

PRIMARY outcome

Timeframe: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment.

Outcome measures

Outcome measures
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Language Specific Attention Treatment Probe
Pre-treatment
56 Percent
Standard Deviation 19
47 Percent
Standard Deviation 29
Language Specific Attention Treatment Probe
Post-treatment
64 Percent
Standard Deviation 24
52 Percent
Standard Deviation 29
Language Specific Attention Treatment Probe
Follow up
61 Percent
Standard Deviation 25
51 Percent
Standard Deviation 27

SECONDARY outcome

Timeframe: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

Change in sustained attention as measured by mean reaction time on the Continuous Performance Test. Participants monitor a screen and press a button for all stimuli except a specific 'no-go' target. The value reported is the mean response time in milliseconds (ms) for correct 'go' trials; a decrease in time indicates improved processing speed.

Outcome measures

Outcome measures
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Continuous Performance Test
Post-treatment
456 ms
Standard Deviation 86
507 ms
Standard Deviation 133
Continuous Performance Test
Pre-treatment
493 ms
Standard Deviation 89
485 ms
Standard Deviation 118
Continuous Performance Test
Follow-up
444 ms
Standard Deviation 66
529 ms
Standard Deviation 158

SECONDARY outcome

Timeframe: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

The Attention Network Test (ANT) is a computerized task that measures the efficiency of three distinct attentional networks: Alerting, Orienting, and Executive (Conflict) control. Alerting Network Score: Calculated by subtracting the mean reaction time (RT) of double-cue trials from no-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater alerting benefit. Orienting Network Score: Calculated by subtracting the mean RT of spatial-cue trials from center-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater orienting benefit. Conflict (Executive) Network Score: Calculated by subtracting the mean RT of congruent flanker trials from incongruent flanker trials. Range: -500ms to +1000ms. Lower scores represent better executive control and less interference from distracting stimuli.

Outcome measures

Outcome measures
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Attention Network Test
Alerting, pre-treatment
51 ms
Standard Deviation 50
43 ms
Standard Deviation 76
Attention Network Test
Alerting, post-treatment
43 ms
Standard Deviation 33
68 ms
Standard Deviation 27
Attention Network Test
Alerting, follow-up
68 ms
Standard Deviation 27
60 ms
Standard Deviation 30
Attention Network Test
Orienting, pre-treatment
14 ms
Standard Deviation 106
14 ms
Standard Deviation 36
Attention Network Test
Orienting, post-treatment
25 ms
Standard Deviation 32
8 ms
Standard Deviation 55
Attention Network Test
Orienting, follow-up
25 ms
Standard Deviation 22
29 ms
Standard Deviation 32
Attention Network Test
Conflict, pre-treatment
66 ms
Standard Deviation 174
123 ms
Standard Deviation 96
Attention Network Test
Conflict, post-treatment
146 ms
Standard Deviation 134
71 ms
Standard Deviation 80
Attention Network Test
Conflict, follow-up
-1 ms
Standard Deviation 376
76 ms
Standard Deviation 61

SECONDARY outcome

Timeframe: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

The Scenario Test assesses daily life communication and discourse through 6 multi-modal scenarios presented via pictures. Participants are prompted to respond to specific communicative situations. Performance is scored based on the effectiveness of communication (verbal and non-verbal) for each item. Results are reported as the average percentage of correct communicative acts out of the total possible score. Range: 0% to 100%, where higher percentages indicate better functional communication and less severe impairment.

Outcome measures

Outcome measures
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Scenario Test
Pre-treatment
47.5 Percent
Standard Deviation 6.7
44 Percent
Standard Deviation 13
Scenario Test
Post-treatment
48.9 Percent
Standard Deviation 6.6
46 Percent
Standard Deviation 8
Scenario Test
Follow-up
49.2 Percent
Standard Deviation 6
45 Percent
Standard Deviation 10

SECONDARY outcome

Timeframe: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

The Revised Token Test assesses auditory comprehension battery; 5 subtests were administered that contributed to the total score. Results are reported as a mean of the 5 subtest scores. Range of scores is 1 to 15, higher scores represent better performance and less severe auditory comprehension impairment.

Outcome measures

Outcome measures
Measure
Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy
n=11 Participants
Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Revised Token Test
1-month Follow-up
14 Scaled score
Standard Deviation 1
12 Scaled score
Standard Deviation 2
Revised Token Test
Pre-treatment
14 Scaled score
Standard Deviation 1
13 Scaled score
Standard Deviation 2
Revised Token Test
Post-treatment
14 Scaled score
Standard Deviation 1
12 Scaled score
Standard Deviation 2

Adverse Events

Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ellyn Riley

Syracuse University

Phone: 315-443-8688

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place