Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by University of Pennsylvania
Sponsor
University of Pennsylvania
Information Provided by (Responsible Party)
University of Pennsylvania
Clinicaltrials.gov Identifier
NCT06842745
Other Study ID Numbers:
857363
First Submitted
February 17, 2025
First Posted
February 23, 2025
Last Update Posted
March 4, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 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.

Previous research has demonstrated that TMS improves language performance in persons with aphasia and the benefit has been shown to be sustained. All studies of which we are aware, however, have included participants with moderate/severe aphasia. The issue of mild aphasia has received little attention to date but as there is an increasing recognition that even very mild language deficits have important negative consequences for employment and social well-being. This study will aim to treat mild aphasia with TMS and SLT emphasizing conversations speech.

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) + SLT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately, 2 months and 4 months after treatment.

Participants will be compensated for their time and travel.

Condition or DiseaseIntervention/Treatment
AphasiaStrokeAphasia Following Cerebral InfarctionAphasia, Acquired
Device: Transcranial Magnetic Stimulation (TMS)Behavioral: Speech-Language Therapy (SLT)

Study Design

Study TypeInterventional
Actual Enrollment24 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitlePersonalized Transcranial Magnetic Stimulation and Constraint Induced Language Therapy to Treat Mild Post-Stroke Aphasia
Study Start DateFebruary 10, 2025
Actual Primary Completion Date3mos 2w from now
Actual Study Completion Date3mos 2w 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 speech-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 speech-language therapy.
Behavioral: Speech-Language Therapy (SLT)
Our SLT protocol draws from two theories and evidence-based cognitive-linguistic frameworks: (1) conversational alignment, which engages priming of lexical and syntactic structures through dialogue and conversation and (2) increased tolerance of memory load in the context of sentence repetition and dialogue tasks. Administration of these tasks will abide by principles of constraint-induced language therapy, i.e., intense treatment schedule and verbal responding only. All participants will receive SLT.

Outcome Measures

Primary Outcome Measures
  1. Sentence Processing
    Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.
Secondary Outcome Measures
  1. Semantic and Phonological Processing
    Change in performance on the TALSA composite semantic processing score and phonological processing score.
  2. Elicited Speech
    Change in performance on the Nicholas \& Brookshire picture description and Story Retell scores.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Left Hemisphere stroke
Stroke occurred more than 6 months ago
Mild Aphasia (WAB AQ score \> 85)
Proficient in English
Exclusion Criteria
Ongoing substance or alcohol abuse
Other neurological disorders, beside stroke (i.e. dementia, traumatic brain injury, multiple sclerosis)
Active psychiatric disorders (i.e. bipolar disorder, schizophrenia)
Pacemaker or cardiac defibrillator
Diagnosis of tinnitus
Epilepsy, or seizure in the past 6 months

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