RecruitingPhase 1/2

Accelerated rTMS vs. Sham for Stroke Apathy

United States40 participantsStarted 2025-08-08

Plain-language summary

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of them. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, investigators are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. This study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). This study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Who can participate

Age range40 Years

SexALL

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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 by the participant or the caregiver/co-participant (AES) of ≥39 * Ability to participate in psychometric testing and cognitive tasks * Intact cortex at the TMS target site as confirmed by pre-treatment MRI * Ability to have a co-participant/caregiver who meets the criteria as detailed below. Exclusion Criteria: * Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage * Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia) * Moderate or severe global aphasia * Visual impairment precluding completion of cognitive tasks * Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; * Pregnancy (to be later confirmed by UPT in any premenopausal female participants) * History of a seizure disorder * Preexisting scalp lesion, wound, bone defect, or hemicraniectomy * Claustrophobia precluding ability to undergo an MRI * Active substance use disorder * Psychotic disorders * Bipolar 1 Disorder * Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide at…

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 at one month post-treatment follow-up

Change in apathy symptoms as measured by the Apathy Evaluation Scale (AES) - Self and Informant Versions

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 six treatment days within two weeks

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-treatmen

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 IDNCT07113067

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Parneet Grewal, MD

843-792-3020 grewalp@musc.edu

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