CompletedPhase 1

Accelerated rTMS for Post-Stroke Apathy

United States14 participantsStarted 2023-12-01

Plain-language summary

This pilot study will investigate the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC) to address apathy symptoms in individuals with chronic stroke.

Who can participate

Age range

40 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

. 40 years old or greater
. Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
. Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale (AES) of ≥39 as rated by the participant or caregiver informant
. Intact cortex under the coil at the stimulation target site confirmed by neuroimaging
. Ability to participate in psychometric testing and cognitive tasks

Exclusion criteria

. Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage

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

Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baseline

Timeframe: Pre-treatment, immediately post-treatment, and weekly for four weeks post-treatment

Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by change in the Review of Systems Criteria compared to baseline

Timeframe: After each session of rTMS during each of three treatment days within one week

Change in global cognition, as measured by the Montreal Cognitive Assessment (MoCA) compared to baseline

Timeframe: Pre-treatment, immediately post-treatment, and at one month post-treatment follow-up

Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baseline

Timeframe: Pre-treatment, immediately post-treatment

Participant retention rate

Timeframe: calculated at the end of the study follow-up assessment period (one month post-treatment)

Patient perception of treatment acceptability as assessed by study-specific questionnaire

Timeframe: After each session of rTMS during each of three treatment days within one week, and at one month post-treatment follow-up

Trial details

NCT IDNCT05878457

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Apathy trials