Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia

NCT03651700 | Completed Phase 2 Results DMC

• 2 other identifiers: 831532-chbdfejhR01DC016800
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure.

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

• Change in WAB-AQ

  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.

  6-months post-treatment

Secondary Outcomes (1)

• Change in Percentage of Items Correct on the PNT

  6-months post-treatment

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

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).

Device: Active TMS; Behavioral: CILT

Sham TMS

SHAM COMPARATOR

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).

Device: Sham TMS; Behavioral: CILT

Interventions

Active TMS DEVICE

Active TMS will be at 90% motor threshold

Active TMS

Sham TMS DEVICE

Sham TMS will be administered

Sham TMS

CILT BEHAVIORAL

60-90 minutes of CILT will be administered during each treatment session

Also known as: Constraint Induced Language Therapy

Active TMS; Sham TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical evidence and MRI or CT verification of a single left hemisphere stroke with moderate to severe aphasia.
• Suffered their stroke at least 6 months prior to their testing
• Must be able to understand the nature of the study, and give informed consent

You may not qualify if:

• Multiple strokes (excluding small lacunar strokes) as defined by brain imaging
• History of substance abuse
• Previous head trauma with loss of consciousness for more than 5 minutes
• Psychiatric illness (We note that subjects will be assessed with the 15-item Geriatric Depression scale. Because depression is very difficult to evaluate in aphasic subjects, potential subjects will not be excluded on the basis of the depression score)
• Chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g. haloperidol, dopaminergics)
• History of or neuropsychological findings suggestive of dementia

Sponsors & Collaborators

• H. Branch Coslett: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daniela Sacchetti, MS
• Organization: Clinical Research Coordinator

danielas@pennmedicine.upenn.edu

215-573-4336

Study Officials

• H. Branch Coslett, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The individual administering TMS will keep the master file of subject assignments, but all other individuals in contact with the subject or their data will be unaware of group assignment. Participants will not be informed of their assignment to active or sham status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to either TMS or sham TMS in a 2:1 allocation ratio.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: March 28, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 14, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)