Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by University of Pennsylvania
Sponsor
University of Pennsylvania
Information Provided by (Responsible Party)
University of Pennsylvania
Clinicaltrials.gov Identifier
NCT06968663
Other Study ID Numbers:
856766
First Submitted
May 4, 2025
First Posted
May 12, 2025
Last Update Posted
April 28, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Aphasia is an acquired disorder of language that occurs in approximately 30% of individuals with stroke and impacts approximately 1 million Americans (see NINDS.NIH.gov). Current treatments for aphasia are only modestly beneficial, so there is a clear need for more efficacious therapy.

Most studies of TMS as a therapy for aphasia have investigated treatment in the chronic phase after stroke (\>6 months post-stroke). Previous research has demonstrated that TMS improves language performance in persons with chronic aphasia and the benefit has been shown to be sustained. Several lines of evidence, however, suggest that TMS treatment in the subacute period may be more effective than interventions in the chronic stage.

One limitation of TMS has been variability in response; TMS has shown good within-subject reliability but more substantial variability between subjects. In recognition of these issues, "electrical field" (e-field) models have been developed to account for these individual differences in anatomy. We will the utilize e-field models in conjunction with an individually determined resting motor threshold to generate a personalized treatment regimen that is likely to ensure that all subjects receive the same TMS intensity relative to their individual motor threshold and greatly reduces the possibility of under- or over-dosing with respect to TMS intensity. We will employ continuous theta-burst stimulation, 600 brief electrical pulses delivered in 40 seconds, over the right front part of the brain (pars triangularis).

Participants who are enrolled can expect to undergo a battery of tests to define their language function as well as a research MRI scan that will be used to guide TMS therapy and to assess the size and location of the stroke and its impact on brain pathways. After baseline testing, subjects will undergo treatment using TMS (or sham) + mCILT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately and 4 months after treatment.

Participants will be compensated for their time and travel.

Condition or DiseaseIntervention/Treatment
StrokeAphasiaAphasia Following Cerebral Infarction
Device: Transcranial Magnetic Stimulation (TMS)Behavioral: Modified Constraint Induced Language Therapy (mCILT)

Study Design

Study TypeInterventional
Actual Enrollment63 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleElectrical Field Guided Transcranial Magnetic Stimulation to Treat Subacute Post-stroke Aphasia
Study Start DateApril 7, 2025
Actual Primary Completion Date3yrs 2mos from now
Actual Study Completion Date3yrs 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Real TMS
Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with language therapy.
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.
Fake TMS
Some of our participants will be randomized to the sham treatment arm where they will receive 10 sessions of fake TMS paired with language therapy.
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.

Outcome Measures

Primary Outcome Measures
  1. Overall language function
    Change in performance on the Western Aphasia Battery (WAB-AQ score). WAB AQ Score is out of 100, where a higher score means less language impairment.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Left hemisphere stroke resulting in aphasia
The stroke must have occurred between 2 and 6 weeks prior to enrollment
Must be able to understand the nature of the study, and give informed consent
English proficiency
Right-handed
Exclusion Criteria
History of serious and/or ongoing issues with substance abuse
Previous head trauma with loss of consciousness for more than 5 minutes
History of major psychiatric illness
Dementia, or other neurological conditions
Epilepsy, or seizure after the stroke event
Pacemaker
Diagnosis of tinnitus
Pregnancy

Contacts and Locations

Sponsors and CollaboratorsUniversity of Pennsylvania
Locations
University of Pennsylvania | Philadelphia Pennsylvania, United States, 19014
Investigators
Principal Investigator: H. Branch Coslett, MD, University of Pennsylvania