Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia (NCT06968663) | Clinical Trial Compass
RecruitingPhase 2
Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
United States63 participantsStarted 2024-08-01
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall language function
Timeframe: From Baseline to 4 months post-interventions