Trial Outcomes & Findings for Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease (NCT NCT04482179)
NCT ID: NCT04482179
Last Updated: 2025-09-15
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
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
12 weeks post-treatment
Results posted on
2025-09-15
Participant Flow
Participants were recruited from 2019-2021 from the Hospital of the University of Pennsylvania and surrounding Philadelphia area medical centers.
A total of 11 participants did not qualify at the time of enrollment due to MMSE scores (8) and medical contraindication (3). One participant dropped out of the study prior to randomization due to travel concerns.
Participant milestones
| Measure |
Active TMS
Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes of TMS will be delivered to the left inferior pars triangularis and to the left posterior superior left temporal gyrus.
Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Sham TMS
Participants will take part in 10 sham TMS sessions over 2 consecutive weeks. Sham TMS mimics the sensory experience (look, sound and feel) of active TMS but does not stimulate the brain. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. The sham TMS will target the same two brain locations - left inferior pars triangularis and the left posterior superior left temporal gyrus.
Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Active TMS
Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes of TMS will be delivered to the left inferior pars triangularis and to the left posterior superior left temporal gyrus.
Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Sham TMS
Participants will take part in 10 sham TMS sessions over 2 consecutive weeks. Sham TMS mimics the sensory experience (look, sound and feel) of active TMS but does not stimulate the brain. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. The sham TMS will target the same two brain locations - left inferior pars triangularis and the left posterior superior left temporal gyrus.
Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease
Baseline characteristics by cohort
| Measure |
Active TMS
n=7 Participants
Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes of TMS will be delivered to the left inferior pars triangularis and to the left posterior superior left temporal gyrus.
Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Sham TMS
n=4 Participants
Participants will take part in 10 sham TMS sessions over 2 consecutive weeks. Sham TMS mimics the sensory experience (look, sound and feel) of active TMS but does not stimulate the brain. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. The sham TMS will target the same two brain locations - left inferior pars triangularis and the left posterior superior left temporal gyrus.
Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 3.66 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
71.27 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Western Aphasia Battery (WAB-AQ) Score
|
80.7 scores on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
87.4 scores on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants
|
83.1 scores on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Philadelphia Naming Test, Items Correct
|
121.0 number of items correct
STANDARD_DEVIATION 37.6 • n=5 Participants
|
157.3 number of items correct
STANDARD_DEVIATION 15.5 • n=7 Participants
|
134.2 number of items correct
STANDARD_DEVIATION 35.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-treatmentThe 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 |
Active TMS
n=5 Participants
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Active TMS: Active TMS will be delivered at 100% motor threshold
CILT: 60-90 minutes of CILT will be administered during each treatment session
|
Sham TMS
n=4 Participants
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
CILT: 60-90 minutes of CILT will be administered during each treatment session
Sham TMS: Sham TMS will be administered
|
|---|---|---|
|
Change in WAB-AQ Score
|
-1.7 score on a scale
Standard Deviation 4.3
|
-.1 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 12 weeks post-treatmentThe secondary outcome measure will be change in naming accuracy on the Philadelphia Naming Test (PNT). PNT naming accuracy is measured as a percentage from 0% to 100% with higher percentages meaning better naming ability. The task involves naming 175 pictures of common objects.
Outcome measures
| Measure |
Active TMS
n=5 Participants
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Active TMS: Active TMS will be delivered at 100% motor threshold
CILT: 60-90 minutes of CILT will be administered during each treatment session
|
Sham TMS
n=4 Participants
There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
CILT: 60-90 minutes of CILT will be administered during each treatment session
Sham TMS: Sham TMS will be administered
|
|---|---|---|
|
Change in Percentage of Items Correct on the PNT
|
-3.2 percentage of correct responses
Standard Deviation 8.2
|
-5.0 percentage of correct responses
Standard Deviation 6.1
|
Adverse Events
Active TMS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Sham TMS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active TMS
n=7 participants at risk
Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes of TMS will be delivered to the left inferior pars triangularis and to the left posterior superior left temporal gyrus.
Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Sham TMS
n=4 participants at risk
Participants will take part in 10 sham TMS sessions over 2 consecutive weeks. Sham TMS mimics the sensory experience (look, sound and feel) of active TMS but does not stimulate the brain. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. The sham TMS will target the same two brain locations - left inferior pars triangularis and the left posterior superior left temporal gyrus.
Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
14.3%
1/7 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
0.00%
0/4 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
Other adverse events
| Measure |
Active TMS
n=7 participants at risk
Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes of TMS will be delivered to the left inferior pars triangularis and to the left posterior superior left temporal gyrus.
Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
Sham TMS
n=4 participants at risk
Participants will take part in 10 sham TMS sessions over 2 consecutive weeks. Sham TMS mimics the sensory experience (look, sound and feel) of active TMS but does not stimulate the brain. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. The sham TMS will target the same two brain locations - left inferior pars triangularis and the left posterior superior left temporal gyrus.
Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
|
|---|---|---|
|
General disorders
Headache
|
28.6%
2/7 • Number of events 4 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
25.0%
1/4 • Number of events 3 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
|
General disorders
Head Pain
|
14.3%
1/7 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
25.0%
1/4 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
|
General disorders
Dizziness
|
0.00%
0/7 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
25.0%
1/4 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
|
Gastrointestinal disorders
Stomach Ache
|
14.3%
1/7 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
0.00%
0/4 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/7 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
25.0%
1/4 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
|
General disorders
Fall
|
0.00%
0/7 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
25.0%
1/4 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 12 weeks.
Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place