Electrical Field Guided Transcranial Magnetic Stimulation to Treat Subacute Post-stroke Aphasia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Leslie Vnenchak, MA, CCC-SLP
leslie.vnenchak@pennmedicine.upenn.edu
215-964-2502
Backup
Daniela Sacchetti, MS
danielas@pennmedicine.upenn.edu
215-964-2502
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 63
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov