Trial Outcomes & Findings for tDCS Intervention in Primary Progressive Aphasia (NCT NCT02606422)
NCT ID: NCT02606422
Last Updated: 2025-01-28
Results Overview
The primary outcome measure was the absolute percentage change in the number of correct letters in the written response, compared to the target response in the trained word lists. This calculation reflects the change in accuracy between two timepoints. For letter accuracy scoring, a rule-based system was used where each letter was assigned one point if correct. Points were deducted for errors such as deletions, additions, substitutions, transpositions, or movements of letters. A second reviewer independently scored the responses and resolved any discrepancies through discussion to ensure consensus. Interrater reliability for letter accuracy scoring was 95%. Average letter accuracy per word was calculated for all trained items. Then the absolute percentage change was calculated by subtracting the earlier time point value (e.g., baseline) from the later one (e.g., immediately after treatment, 2 weeks post, and 2 months post), reflecting the change in accuracy.
COMPLETED
NA
61 participants
Change from Baseline to Immediately after treatment (3 weeks), 2 weeks post treatment (5 weeks), and 2 months post-treatment (11 weeks) for each period of intervention
2025-01-28
Participant Flow
61 patients were consented for eligibility between the study start date and end date at our lab located at Johns Hopkins Hospital.
All 61 participants that were consented started a 12-week natural progression observation where they did not recieve any therapy. After the 12-week period, 37 participants were randomized. Of those not randomized,13 had a primary deficit of apraxia of speech, 7 chose not to participate, 1 did not have measureable language deficits, 3 chose to participate in another trial.
Participant milestones
| Measure |
Active HD-tDCS Plus Speech-Language Therapy, Then Sham Plus Speech-Language Therapy
Participants first received active tDCS with speech therapy for two weeks. Active high-Definition transcranial Direct Current Stimulation (HD-tDCS) was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation was delivered at an intensity of 2 miliamps (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 coulombs (C)/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming. After a washout period of 3 months, they then received sham tDCS plus speech therapy for 2 weeks. Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping, the intensity dropped to 0 mA
|
Sham Plus Speech-Language Therapy, Then Active HD-tDCS Plus Speech-Language Therapy
Participants first received sham tDCS with speech therapy for 2 weeks. Sham HD-tDCS was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping the intensity dropped to 0 mA. After a washout period of 3 months, they then received active tDCS plus speech therapy for two weeks. The stimulation was delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming.
|
|---|---|---|
|
Intervention Phase 1 (3 Weeks)
STARTED
|
20
|
17
|
|
Intervention Phase 1 (3 Weeks)
COMPLETED
|
20
|
17
|
|
Intervention Phase 1 (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Phase 1: Immediate Follow up
STARTED
|
20
|
17
|
|
Phase 1: Immediate Follow up
COMPLETED
|
18
|
17
|
|
Phase 1: Immediate Follow up
NOT COMPLETED
|
2
|
0
|
|
Phase 1, 2-Week Follow-up (Washout)
STARTED
|
18
|
17
|
|
Phase 1, 2-Week Follow-up (Washout)
COMPLETED
|
16
|
17
|
|
Phase 1, 2-Week Follow-up (Washout)
NOT COMPLETED
|
2
|
0
|
|
Phase 1 2-Month Follow-up (Washout)
STARTED
|
16
|
17
|
|
Phase 1 2-Month Follow-up (Washout)
COMPLETED
|
15
|
16
|
|
Phase 1 2-Month Follow-up (Washout)
NOT COMPLETED
|
1
|
1
|
|
Intervention Phase 2 (3 Weeks)
STARTED
|
15
|
16
|
|
Intervention Phase 2 (3 Weeks)
COMPLETED
|
15
|
16
|
|
Intervention Phase 2 (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Phase 2: Immediate Follow-up
STARTED
|
15
|
16
|
|
Phase 2: Immediate Follow-up
COMPLETED
|
15
|
16
|
|
Phase 2: Immediate Follow-up
NOT COMPLETED
|
0
|
0
|
|
Phase 2, 2-Week Follow-up (Washout)
STARTED
|
15
|
16
|
|
Phase 2, 2-Week Follow-up (Washout)
COMPLETED
|
15
|
15
|
|
Phase 2, 2-Week Follow-up (Washout)
NOT COMPLETED
|
0
|
1
|
|
Phase 2: 2-Month Follow-up (Washout)
STARTED
|
15
|
15
|
|
Phase 2: 2-Month Follow-up (Washout)
COMPLETED
|
15
|
15
|
|
Phase 2: 2-Month Follow-up (Washout)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active HD-tDCS Plus Speech-Language Therapy, Then Sham Plus Speech-Language Therapy
Participants first received active tDCS with speech therapy for two weeks. Active high-Definition transcranial Direct Current Stimulation (HD-tDCS) was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation was delivered at an intensity of 2 miliamps (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 coulombs (C)/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming. After a washout period of 3 months, they then received sham tDCS plus speech therapy for 2 weeks. Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping, the intensity dropped to 0 mA
|
Sham Plus Speech-Language Therapy, Then Active HD-tDCS Plus Speech-Language Therapy
Participants first received sham tDCS with speech therapy for 2 weeks. Sham HD-tDCS was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping the intensity dropped to 0 mA. After a washout period of 3 months, they then received active tDCS plus speech therapy for two weeks. The stimulation was delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming.
|
|---|---|---|
|
Phase 1: Immediate Follow up
Withdrawal by Subject
|
2
|
0
|
|
Phase 1, 2-Week Follow-up (Washout)
Withdrawal by Subject
|
2
|
0
|
|
Phase 1 2-Month Follow-up (Washout)
Withdrawal by Subject
|
1
|
1
|
|
Phase 2, 2-Week Follow-up (Washout)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active HD-tDCS Plus Speech-Language Therapy, Then Sham Plus Speech-Language Therapy
n=20 Participants
Participants first received active tDCS with speech therapy for two weeks. Active HD-tDCS was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation was delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming. After a washout period of 3 months, they then received sham tDCS plus speech therapy for 2 weeks. Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping, the intensity dropped to 0 mA
|
Sham Plus Speech-Language Therapy, Then Active HD-tDCS Plus Speech-Language Therapy
n=17 Participants
Participants first received sham tDCS with speech therapy for 2 weeks. Sham HD-tDCS was applied at the beginning of 45 min speech-language therapy session and lasted for 20 min. The electrical current was administered to a pre-specified region of the brain (inferior frontal gyrus). Speech-language therapy will be administered during sham stimulation. Current was administered in a ramp-line fashion but after the ramping the intensity dropped to 0 mA. After a washout period of 3 months, they then received active tDCS plus speech therapy for two weeks. The stimulation was delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy consisted of oral and written naming.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.45 years
STANDARD_DEVIATION 7.40 • n=20 Participants
|
68.82 years
STANDARD_DEVIATION 7.05 • n=17 Participants
|
67.45 years
STANDARD_DEVIATION 7.16 • n=37 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
8 Participants
n=17 Participants
|
17 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
9 Participants
n=17 Participants
|
20 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
17 Participants
n=17 Participants
|
37 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Immediately after treatment (3 weeks), 2 weeks post treatment (5 weeks), and 2 months post-treatment (11 weeks) for each period of interventionPopulation: Participants who completed Written Naming
The primary outcome measure was the absolute percentage change in the number of correct letters in the written response, compared to the target response in the trained word lists. This calculation reflects the change in accuracy between two timepoints. For letter accuracy scoring, a rule-based system was used where each letter was assigned one point if correct. Points were deducted for errors such as deletions, additions, substitutions, transpositions, or movements of letters. A second reviewer independently scored the responses and resolved any discrepancies through discussion to ensure consensus. Interrater reliability for letter accuracy scoring was 95%. Average letter accuracy per word was calculated for all trained items. Then the absolute percentage change was calculated by subtracting the earlier time point value (e.g., baseline) from the later one (e.g., immediately after treatment, 2 weeks post, and 2 months post), reflecting the change in accuracy.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=34 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=31 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 1: Change from baseline to immediately after treatment
|
39.4 absolute percent change
Standard Error 5.1
|
28.4 absolute percent change
Standard Error 5.2
|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 1: change from baseline to 2-weeks post treatment
|
33.1 absolute percent change
Standard Error 4.7
|
20.0 absolute percent change
Standard Error 5.1
|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 1: change from baseline to 2-months post treatment. (Baseline for Phase 2)
|
27.5 absolute percent change
Standard Error 5.5
|
11.7 absolute percent change
Standard Error 2.7
|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 2: Change from baseline to immediate follow-up
|
27.0 absolute percent change
Standard Error 5.4
|
25.5 absolute percent change
Standard Error 6.2
|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 2:change from baseline to 2-weeks post treatment
|
13.2 absolute percent change
Standard Error 4.9
|
13.2 absolute percent change
Standard Error 6.7
|
|
Absolute Percent Change in Written Naming (Trained Items)
Phase 2: change from baseline to 2-months post treatment
|
9.1 absolute percent change
Standard Error 4.1
|
8.9 absolute percent change
Standard Error 4.6
|
PRIMARY outcome
Timeframe: Change from Baseline to Immediately after treatment (3 weeks), 2 weeks post treatment (5 weeks), and 2 months post-treatment (11 weeks) for each period of interventionPopulation: Participants who completed written naming
The primary outcome measure was the absolute percentage change in the number of correct letters in the written response, compared to the target response in the untrained word lists.This calculation reflects the change in accuracy between two timepoints. For letter accuracy scoring, a rule-based system was used where each letter was assigned one point if correct. Points were deducted for errors such as deletions, additions, substitutions, transpositions, or movements of letters. A second reviewer independently scored the responses and resolved any discrepancies through discussion to ensure consensus. Interrater reliability for letter accuracy scoring was 95%. Average letter accuracy per word was calculated for all untrained items. Then the absolute percentage change was calculated by subtracting the earlier time point value (e.g., baseline) from the later one (e.g., immediately after treatment, 2 weeks post, and 2 months post), reflecting the change in accuracy.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=34 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=31 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 1: change from baseline immediately after treatment
|
14.6 absolute percent change
Standard Error 2.7
|
9.6 absolute percent change
Standard Error 2.3
|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 1: change from baseline 2-weeks post treatment
|
15.6 absolute percent change
Standard Error 3.9
|
6.6 absolute percent change
Standard Error 3.4
|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 1: change from baseline 2-months post treatment. (Baseline for Phase 2)
|
17.3 absolute percent change
Standard Error 3.6
|
3.0 absolute percent change
Standard Error 3.0
|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 2: change from baseline immediately after treatment
|
9.9 absolute percent change
Standard Error 2.6
|
5.4 absolute percent change
Standard Error 2.5
|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 2: change from baseline 2-weeks post treatment
|
7.3 absolute percent change
Standard Error 3.9
|
0.7 absolute percent change
Standard Error 2.2
|
|
Absolute Percent Change in Written Naming (Untrained Items)
Phase 2: change from baseline 2-months post treatment
|
9.9 absolute percent change
Standard Error 1.9
|
-3.4 absolute percent change
Standard Error 2.7
|
PRIMARY outcome
Timeframe: Change from Baseline to Immediately after treatment (3 weeks), 2 weeks post treatment (5 weeks), and 2 months post-treatment (11 weeks) for each period of interventionPopulation: Participants who completed oral naming.
The percent accuracy for each participant's trained oral naming list was calculated, with scores ranging from 0% to 100%. A score of 0% indicates no correct responses, while 100% represents perfect accuracy. Higher percentages reflect better performance. To assess changes in performance from pre- to post-treatment, the percent accuracy for untrained items was compared before and after the intervention. The absolute percentage change was then calculated by subtracting the accuracy at the baseline time point (e.g., baseline) from the accuracy at the later time points (e.g., immediately after treatment, 2 weeks post, and 2 months post). This reflects the change in the participant's ability to name trained items, expressed as absolute percent change. A positive difference indicates improvement in naming accuracy, with a larger change reflecting greater improvement. A negative difference indicates a decline, with a larger change reflecting greater deterioration in naming ability.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=29 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=25 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 1: change from baseline immediately after treatment
|
38.8 absolute percent change
Standard Deviation 7.3
|
26.9 absolute percent change
Standard Deviation 4.7
|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 1: change from baseline 2-weeks post treatment
|
30 absolute percent change
Standard Deviation 7.5
|
21.3 absolute percent change
Standard Deviation 4.9
|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 1: change from baseline 2-months post treatment. (Baseline for Phase 2)
|
24.9 absolute percent change
Standard Deviation 8.5
|
15.3 absolute percent change
Standard Deviation 4.8
|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 2: change from baseline immediately after treatment
|
23.5 absolute percent change
Standard Deviation 5.0
|
26.5 absolute percent change
Standard Deviation 10.9
|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 2: change from baseline 2-weeks post treatment
|
15.6 absolute percent change
Standard Deviation 4.1
|
22.6 absolute percent change
Standard Deviation 8.9
|
|
Absolute Percent Change in Oral Naming (Trained Items)
Phase 2: change from baseline 2-months post treatment
|
6.5 absolute percent change
Standard Deviation 4.3
|
6.3 absolute percent change
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: Change from Baseline to Immediately after treatment (3 weeks), 2 weeks post treatment (5 weeks), and 2 months post-treatment (11 weeks) for each period of interventionPopulation: Participants who completed oral naming.
The percent accuracy for each participant's untrained oral naming list was calculated, with scores ranging from 0% to 100%. A score of 0% indicates no correct responses, while 100% represents perfect accuracy. Higher percentages reflect better performance. To assess changes in performance from pre- to post-treatment, the percent accuracy for untrained items was compared before and after the intervention. The absolute percentage change was then calculated by subtracting the accuracy at the baseline time point (e.g., baseline) from the accuracy at the later time points (e.g., immediately after treatment, 2 weeks post, and 2 months post). This reflects the change in the participant's ability to name trained items, expressed as absolute percent change. A positive difference indicates improvement in naming accuracy, with a larger change reflecting greater improvement. A negative difference indicates a decline, with a larger change reflecting greater deterioration in naming ability.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=29 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=25 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 1: change from baseline immediately after treatment
|
8.1 absolute percent change
Standard Deviation 2.4
|
8.9 absolute percent change
Standard Deviation 4.6
|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 1: change from baseline 2-weeks post treatment
|
4.8 absolute percent change
Standard Deviation 2.5
|
7.9 absolute percent change
Standard Deviation 3.5
|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 1: change from baseline 2-months post treatment. (Baseline for Phase 2)
|
3.9 absolute percent change
Standard Deviation 4.0
|
2.6 absolute percent change
Standard Deviation 4.6
|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 2: change from baseline immediately after treatment
|
4.8 absolute percent change
Standard Deviation 2.6
|
-1.8 absolute percent change
Standard Deviation 7.2
|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 2: change from baseline 2-weeks post treatment
|
1.8 absolute percent change
Standard Deviation 2.1
|
0.4 absolute percent change
Standard Deviation 2.9
|
|
Absolute Percent Change in Oral Naming (Untrained Items)
Phase 2: change from baseline 2-months post treatment
|
4.6 absolute percent change
Standard Deviation 2.7
|
-6.7 absolute percent change
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Change from baseline to immediate follow-up (3 weeks).Population: Participants who completed SOAP test
The SOAP test is a test that has been shown to measure comprehension of simple and complex sentence structures. It contains sentences with different syntactic complexities: subject relatives, object relative, active and passive voice. The participant has to listen to a sentence and choose the correct picture that corresponds to its meaning amongst 3 alternatives. Scores range from 0-40 with higher scores indicating better comprehension. For each participant in each group absolute change from before to after treatment was calculated and the mean absolute change for the group was calculated.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=12 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=17 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Change in Sentence Comprehension as Measured by the Subject Object Active Passive (SOAP) Test
|
3.250 score on a scale
Standard Deviation 3.911
|
-0.412 score on a scale
Standard Deviation 3.658
|
SECONDARY outcome
Timeframe: Change from before treatment to immediate follow up (3 weeks)Population: fMRI data were collected from 33 participants with PPA. One participant completed treatment but data was excluded due to rediagnosis. Analysis was only performed for period 1 of the intervention so only 16 participants with tDCS and 16 with sham are compared.
Using resting-state functional magnetic resonance imaging (rsfMRI), investigators will investigate whether tDCS intervention will result in different changes in connectivity between the targeted area (left inferior frontal gyrus) and other nodes in the brain. Global connectivity is measured through the participation coefficient. The participation coefficient is scored on a scale from -1 to +1. Compared with healthy controls a score closer to +1 was associated with worse dementia severity.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=16 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Active tDCS plus Speech-Language Therapy: Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
|
Sham Plus Speech-Language Therapy
n=16 Participants
Sham HD-tDCS will be applied at the beginning of 45min speech-language therapy session.
Sham plus Speech-Language Therapy: Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
|
|---|---|---|
|
Change in Functional Connectivity
|
-0.08 score on a scale
Standard Deviation 0.02
|
0.02 score on a scale
Standard Deviation 0.01
|
Adverse Events
Active HD-tDCS Plus Speech-Language Therapy
Sham Plus Speech-Language Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kyrana Tsapkini
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place