NCT06968663 Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
| NCT ID | NCT06968663 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Pennsylvania |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 63 participants in total. It began in 2024-08-01 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
H. Branch Coslett, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06968663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06968663 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06968663 currently recruiting?
Yes, NCT06968663 is actively recruiting participants. Contact the research team at leslie.vnenchak@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06968663 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06968663 clinical trial?
NCT06968663 is sponsored by University of Pennsylvania. The principal investigator is H. Branch Coslett, MD at University of Pennsylvania. The trial plans to enroll 63 participants.
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