Trial Outcomes & Findings for Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia (NCT NCT03651700)

Last Updated: 2025-10-14

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

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

6-months post-treatment

Results posted on

2025-10-14

Participant Flow

Participants were recruited from 2019-2024 from the Hospital of the University of Pennsylvania, surrounding Philadelphia area medical centers and aphasia support groups.

A total of 36 participants did not qualify due to medical contraindications (14) or aphasia severity (22). Nine participants dropped out of the study prior to randomization due to safety concerns (1), inability to complete MRI scan (3), lost to follow-up (2), travel concerns (1), no longer interested in participating (2).

Participant milestones

Participant milestones
Measure	Active TMS Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS Participants will take part in 10 Sham TMS sessions over 2 consecutive weeks for 20 minutes each day. 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 brain location - left inferior pars triangularis. Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Overall Study STARTED	26	15
Overall Study COMPLETED	25	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active TMS Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS Participants will take part in 10 Sham TMS sessions over 2 consecutive weeks for 20 minutes each day. 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 brain location - left inferior pars triangularis. 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

Baseline Characteristics

Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TMS n=26 Participants Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS n=15 Participants Participants will take part in 10 Sham TMS sessions over 2 consecutive weeks for 20 minutes each day. 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 brain location - left inferior pars triangularis. Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).	Total n=41 Participants Total of all reporting groups
Age, Continuous	57.73 years STANDARD_DEVIATION 10.62 • n=5 Participants	61.67 years STANDARD_DEVIATION 10.87 • n=7 Participants	59.17 years STANDARD_DEVIATION 10.88 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	13 Participants n=7 Participants	16 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Western Aphasia Battery (WAB-AQ) Score	66.6 score on a scale STANDARD_DEVIATION 19.9 • n=5 Participants	68.8 score on a scale STANDARD_DEVIATION 18.5 • n=7 Participants	67.4 score on a scale STANDARD_DEVIATION 18.7 • n=5 Participants
Philadelphia Naming Test, Items Correct	110.4 number of items correct STANDARD_DEVIATION 57.0 • n=5 Participants	114.0 number of items correct STANDARD_DEVIATION 42.6 • n=7 Participants	111.7 number of items correct STANDARD_DEVIATION 51.8 • n=5 Participants

PRIMARY outcome

Timeframe: 6-months post-treatment

Outcome measures

Outcome measures
Measure	Active TMS n=25 Participants There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS n=15 Participants There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz sham TMS will be delivered to the inferior pars triangular. 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). Sham TMS: Sham TMS will be administered CILT: 60-90 minutes of CILT will be administered during each treatment session
Change in WAB-AQ	3.0 score on a scale Standard Deviation 3.8	2.8 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 6-months post-treatment

The 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

Outcome measures
Measure	Active TMS n=25 Participants There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS n=15 Participants There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz sham TMS will be delivered to the inferior pars triangular. 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). Sham TMS: Sham TMS will be administered CILT: 60-90 minutes of CILT will be administered during each treatment session
Change in Percentage of Items Correct on the PNT	3.4 score on a scale Standard Deviation 8.9	3.4 score on a scale Standard Deviation 9.1

Adverse Events

Active TMS

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Sham TMS

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active TMS n=26 participants at risk Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS n=15 participants at risk Participants will take part in 10 Sham TMS sessions over 2 consecutive weeks for 20 minutes each day. 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 brain location - left inferior pars triangularis. Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Nervous system disorders Seizure	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Cancer Diagnosis	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.

Other adverse events

Additional Information

Daniela Sacchetti, MS

Clinical Research Coordinator

Phone: 215-573-4336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active TMS n=26 participants at risk Participants will receive 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. 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 at 90% motor threshold CILT: 60-90 minutes of CILT will be administered during each treatment session	Sham TMS n=15 participants at risk Participants will take part in 10 Sham TMS sessions over 2 consecutive weeks for 20 minutes each day. 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 brain location - left inferior pars triangularis. Each sham TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
Cardiac disorders Heart Failure	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Nervous system disorders Concussion	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Nervous system disorders Facial Tingling	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Musculoskeletal and connective tissue disorders Broken Bone	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	13.3% 2/15 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Infections and infestations Ear Infection	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Nosebleed	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Eye disorders Macular Edema	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Surgical and medical procedures Vagus Nerve Stimulator	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Infections and infestations Cut/Wound Care	7.7% 2/26 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Nervous system disorders Syncope	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Dehydration	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Headache	23.1% 6/26 • Number of events 6 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 3 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Renal and urinary disorders Bladder Infection	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Stiff Neck	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Psychiatric disorders Anxiety Attach	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
General disorders Jaw Pain	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/26 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	6.7% 1/15 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Cardiac disorders Atrial Fibrilation	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Nervous system disorders Vertigo	3.8% 1/26 • Number of events 1 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.
Respiratory, thoracic and mediastinal disorders Asthma Attack	3.8% 1/26 • Number of events 2 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.	0.00% 0/15 • From baseline, adverse event data were collected over a period of time consisting of 6 months. Adverse event (AEs) information was collected daily during treatment sessions, as well as each follow-up visit.