Trial Outcomes & Findings for Treating Primary Progressive Aphasia (PPA) Using tDCS (NCT NCT04566731)
NCT ID: NCT04566731
Last Updated: 2025-11-13
Results Overview
The primary outcome measure will be the change in score on the Western Aphasia Battery Aphasia Quotient (WAB-AQ), a score assessing overall aphasia recovery. Scores can range from 0-100, with higher scores representing better outcomes. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline to 12 weeks; baseline to 24 weeks when available
Results posted on
2025-11-13
Participant Flow
Participants were recruited from July 2020-July 2024 from the Hospital of the University of Pennsylvania and surrounding Philadelphia area medical centers.
A total of 3 participants did not qualify at the time of enrollment due to low MMSE scores (2) and diagnosis change that no longer met our PPA criteria (1). A total of 2 participants dropped out of the study before they were randomized due to travel concerns.
Participant milestones
| Measure |
tDCS + CILT First, Then Sham tDCS + CILT
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after tDCS + CILT treatment.
After a 12 week washout period, participants will then crossover to the Sham tDCS condition. Follow-up language assessments will be completed immediately, 6 weeks,12 weeks and 24 weeks after Sham tDCS + CILT treatment.
|
Sham tDCS + CILT First, Then tDCS + CILT
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathode is placed over O1. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time (about 30 seconds) and then turn-off. Most people cannot tell the difference between real and sham stimulation. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after Sham tDCS + CILT treatment.
After a 12 week washout period, participants will then crossover to the tDCS condition. Follow-up language assessments will be completed immediately, 6 weeks,12 weeks and 24 weeks after tDCS + CILT treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Primary Progressive Aphasia (PPA) Using tDCS
Baseline characteristics by cohort
| Measure |
tDCS + CILT First, Then Sham + CILT
n=10 Participants
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Participants will then crossover to the Sham tDCS condition.
|
Sham tDCS + CILT First, Then tDCS + CILT
n=8 Participants
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathode is placed over O1. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time (about 30 seconds) and then turn-off. Most people cannot tell the difference between real and sham stimulation. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Participants will then crossover into the tDCS condition.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 5.89 • n=10 Participants
|
68 years
STANDARD_DEVIATION 6.65 • n=10 Participants
|
67.7 years
STANDARD_DEVIATION 6.24 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
18 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
18 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Western Aphasia Battery (WAB-AQ) Score
|
74.9 scores on a scale
STANDARD_DEVIATION 12.84 • n=10 Participants
|
78.0 scores on a scale
STANDARD_DEVIATION 13.48 • n=10 Participants
|
76.3 scores on a scale
STANDARD_DEVIATION 13.2 • n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks; baseline to 24 weeks when availablePopulation: 24 week follow-up data are not available for individuals randomized to the tDCS + CILT first, then Sham tDCS + CILT group because there is no 24 week follow-up for the first arm. 24 week follow-up data are not available for individuals randomized to the Sham tDCS + CILT first, then tDCS + CILT group because there is no 24 week follow-up for the first arm.
The primary outcome measure will be the change in score on the Western Aphasia Battery Aphasia Quotient (WAB-AQ), a score assessing overall aphasia recovery. Scores can range from 0-100, with higher scores representing better outcomes. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.
Outcome measures
| Measure |
tDCS + CILT First, Then Sham tDCS + CILT
n=9 Participants
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Participants will then crossover to the Sham tDCS condition.
|
Sham tDCS + CILT First, Then tDCS + CILT
n=5 Participants
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathode is placed over O1. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time (about 30 seconds) and then turn-off. Most people cannot tell the difference between real and sham stimulation. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Participants will then crossover into the tDCS condition.
|
|---|---|---|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
tDCS: Baseline
|
74.4 scores on a scale
Standard Deviation 14.2
|
76.5 scores on a scale
Standard Deviation 12.5
|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
tDCS: 12 Week Follow-up
|
72.5 scores on a scale
Standard Deviation 15.9
|
76.0 scores on a scale
Standard Deviation 15.9
|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
Sham: Baseline
|
72.5 scores on a scale
Standard Deviation 15.9
|
80.7 scores on a scale
Standard Deviation 9.0
|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
Sham: 12 Week Follow-up
|
72.2 scores on a scale
Standard Deviation 17.6
|
76.5 scores on a scale
Standard Deviation 12.5
|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
Active: 24 Week Follow-up
|
—
|
75.0 scores on a scale
Standard Deviation 15.9
|
|
Western Aphasia Battery Aphasia Quotient (WAB-AQ)
Sham: 24 Week Follow-up
|
67.5 scores on a scale
Standard Deviation 21.1
|
—
|
Adverse Events
tDCS + CILT
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham tDCS + CILT
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
tDCS + CILT
n=18 participants at risk
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after treatment.
|
Sham tDCS + CILT
n=18 participants at risk
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathode is placed over O1. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time (about 30 seconds) and then turn-off. Most people cannot tell the difference between real and sham stimulation. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after treatment.
|
|---|---|---|
|
Surgical and medical procedures
Hip replacement
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
Other adverse events
| Measure |
tDCS + CILT
n=18 participants at risk
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after treatment.
|
Sham tDCS + CILT
n=18 participants at risk
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathode is placed over O1. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time (about 30 seconds) and then turn-off. Most people cannot tell the difference between real and sham stimulation. Subjects will simultaneously participate in a modified constraint-induced language therapy.
Follow-up language assessments will be completed immediately, 6 weeks and 12 weeks after treatment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
11.1%
2/18 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
|
General disorders
Fall
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
|
General disorders
Headache
|
5.6%
1/18 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
|
Surgical and medical procedures
ear biopsy
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/18 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
5.6%
1/18 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 36 weeks (12 weeks for arm 1 and 24 weeks for arm 2).
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit. This is a crossover study, meaning all participants received the real intervention at some point during their participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place