Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06968663
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Aphasia
  • Aphasia Following Cerebral Infarction
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    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.
  • Modified Constraint Induced Language Therapy (mCILT) — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Apr 8, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Overall language function [ Time Frame: From Baseline to 4 months post-interventions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19014
Leslie Vnenchak, MA, CCC-SLP
[email protected]
215-964-2502
Daniela Sacchetti, MS
[email protected]
215-964-2502
H. Branch Coslett, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Pennsylvania· Philadelphia, PA

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