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Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia

NCT03651700 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-10-14

Study results available
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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

Interventions

DEVICE

Active TMS

Active TMS will be at 90% motor threshold

DEVICE

Sham TMS

Sham TMS will be administered

BEHAVIORAL

CILT

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • H. Branch Coslett

    lead OTHER

Principal Investigators

  • H. Branch Coslett, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651700 on ClinicalTrials.gov