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RecruitingPhase 1, Phase 2NCT07113067

Accelerated rTMS vs. Sham for Stroke Apathy

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Plain-language summary for patients

Trial Parameters

ConditionApathy
SponsorMedical University of South Carolina
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment40
SexALL
Min Age40 Years
Max AgeN/A
Start Date2025-08-08
Completion2027-06-30
Interventions
MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active)MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham)Brainsight Neuronavigation System

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Brief 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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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.

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

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