Trial Outcomes & Findings for TMS for the Treatment of Primary Progressive Aphasia (NCT NCT04188067)
NCT ID: NCT04188067
Last Updated: 2025-11-04
Results Overview
The outcome is the caudal Middle Frontal Gyrus resting-state functional connectivity z-scores, ranging between 0 (indicating no connectivity) and 1 (indicating strongest connectivity). We report the difference of functional connectivity scores between Baseline and after two weeks (Monday-Friday; 10 days total) of TMS stimulation post-treatment (post-treatment minus Baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline and post treatment
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Active, then Sham rTMS
In this within-subject crossover design, participants first received 2 weeks of active TMS treatment at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. After a 4 week washout during which no TMS was administered, participants received 2 weeks of sham (placebo) TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
Sham, then Active rTMS
In this within-subject crossover design, participants first received 2 weeks of sham (placebo) TMS treatment. After a 4 week washout during which no TMS was administered, participants received 2 weeks of active TMS at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMS for the Treatment of Primary Progressive Aphasia
Baseline characteristics by cohort
| Measure |
Active, then Sham rTMS
n=8 Participants
In this within-subject crossover design, participants first received 2 weeks of active TMS treatment at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. After a 4 week washout during which no TMS was administered, participants received 2 weeks of sham (placebo) TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
Sham, then Active rTMS
n=2 Participants
In this within-subject crossover design, participants first received 2 weeks of sham (placebo) TMS treatment. After a 4 week washout during which no TMS was administered, participants received 2 weeks of active TMS at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Age, Continuous
|
70 Years
STANDARD_DEVIATION 10.66 • n=15 Participants
|
78.5 Years
STANDARD_DEVIATION 7.78 • n=161 Participants
|
71.7 Years
STANDARD_DEVIATION 10.39 • n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-treatmentThe outcome is the Boston Naming Test (BNT), a 30-item naming task scored from 0 to 30. Higher scores indicate greater performance. We report the change between Baseline and after two weeks (Monday-Friday; 10 days total) of TMS stimulation post-treatment (post-treatment minus Baseline).
Outcome measures
| Measure |
Active, then Sham rTMS
n=8 Participants
In this within-subject crossover design, participants first received 2 weeks of active TMS treatment at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. After a 4 week washout during which no TMS was administered, participants received 2 weeks of sham (placebo) TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
Sham, then Active rTMS
n=2 Participants
In this within-subject crossover design, participants first received 2 weeks of sham (placebo) TMS treatment. After a 4 week washout during which no TMS was administered, participants received 2 weeks of active TMS at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
|---|---|---|
|
Changes in Language as Measured Through the Boston Naming Test (BNT)
Active
|
1.8 Objects
Standard Deviation 2.19
|
2.5 Objects
Standard Deviation 0
|
|
Changes in Language as Measured Through the Boston Naming Test (BNT)
Sham
|
0.063 Objects
Standard Deviation 2.06
|
0.5 Objects
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Baseline and post treatmentThe outcome is the caudal Middle Frontal Gyrus resting-state functional connectivity z-scores, ranging between 0 (indicating no connectivity) and 1 (indicating strongest connectivity). We report the difference of functional connectivity scores between Baseline and after two weeks (Monday-Friday; 10 days total) of TMS stimulation post-treatment (post-treatment minus Baseline).
Outcome measures
| Measure |
Active, then Sham rTMS
n=8 Participants
In this within-subject crossover design, participants first received 2 weeks of active TMS treatment at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. After a 4 week washout during which no TMS was administered, participants received 2 weeks of sham (placebo) TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
Sham, then Active rTMS
n=2 Participants
In this within-subject crossover design, participants first received 2 weeks of sham (placebo) TMS treatment. After a 4 week washout during which no TMS was administered, participants received 2 weeks of active TMS at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA).
|
|---|---|---|
|
Changes in Brain Network Connectivity Through a Comparison of the Strength of Resting-state Functional Connectivity Metric
Active
|
-0.082 Functional connectivity values
Standard Deviation 0.12
|
-0.27 Functional connectivity values
Standard Deviation 0.33
|
|
Changes in Brain Network Connectivity Through a Comparison of the Strength of Resting-state Functional Connectivity Metric
Sham
|
-0.011 Functional connectivity values
Standard Deviation 0.13
|
-0.071 Functional connectivity values
Standard Deviation 0.040
|
Adverse Events
Active, then Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham, then Active rTMS
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
Dr. Alexandra Touroutoglou PhD
Massachusetts General Hospital
Phone: 6176436348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place