Accelerated rTMS vs. Sham for Stroke Apathy

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Aug 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called accelerated repetitive transcranial magnetic stimulation (rTMS) to help people who feel a lack of motivation, called apathy, after having a stroke. Apathy can make it hard for someone to enjoy life or take part in activities they used to care about. Right now, there aren’t any approved medicines specifically for apathy after stroke, so this study is testing whether rTMS—a safe and painless way to stimulate a specific part of the brain—can improve motivation and quality of life.

The trial is looking for adults aged 40 or older who had a stroke at least six months ago and are experiencing noticeable apathy. Participants need to be able to do some simple thinking and memory tests and have a caregiver or family member who knows them well and can help with the study. During the study, participants will receive either the real rTMS treatment or a sham (placebo) version, and researchers will check if the treatment is safe, comfortable, and helpful. This study is important because it could lead to new ways to support people dealing with apathy after stroke, improving both their well-being and the lives of their caregivers.

Gender

ALL

Eligibility criteria

• 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 attempt in the previous year
• For CO-PARTICIPANT/CAREGIVER:
• Inclusion Criteria:
• • Age 18 years or older
• • Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's cognitive and everyday functioning.
• Exclusion Criteria:
• • - Unable to engage with study procedures in which Co-Participant input is needed.