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Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia

NCT06968663 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-04-29

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) is an effective treatment for aphasia when delivered in the subacute stage after stroke.

The main questions this study aims to answer are:

1. Can TMS combined with mCILT improve overall speech?
2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and mCILT treatment?

Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat subacute aphasia.

Importantly, this trial will use electric field guided TMS to identify optimal and individualized stimulation intensity and site targeting.

Participants will:

* Complete a screening and medical intake to determine eligibility
* Undergo MRI scans
* Participate in 10 consecutive sessions (Monday-Friday) of TMS and mCILT treatment
* Complete follow-up assessments immediately and 4 months after treatment

Conditions

  • Stroke
  • Aphasia
  • Aphasia Following Cerebral Infarction

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS)

TMS, is a form of non-invasive brain stimulation, that uses magnetic pulses to stimulate specific areas of the brain. In this study we will utilize theta-burst stimulation which uses a higher frequency pulse of 50 Hz delivered for 40 seconds for a total of 600 pulses.

BEHAVIORAL

Modified Constraint Induced Language Therapy (mCILT)

Constraint-induced language therapy (CILT) is a treatment approach for aphasia that focuses on forcing the patient to use their impaired language skills, while restricting the use of compensatory strategies like gestures or writing. All participants will receive mCILT.

Sponsors & Collaborators

Principal Investigators

  • H. Branch Coslett, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06968663 on ClinicalTrials.gov