NCT07113067RecruitingPhase 1/2
Accelerated rTMS vs. Sham for Stroke Apathy
Accelerated rTMS for Post-stroke Apathy: A Double-blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Aug 2025
- Start date
- 8 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Stroke
- NCT number
- NCT07113067
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 8 Aug 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
- 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:
Other illness
- Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
- 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;
- History of a seizure disorder
- Active substance use disorder
- Psychotic disorders
- Bipolar 1 Disorder
Other
- Moderate or severe global aphasia
- Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
- Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
- Claustrophobia precluding ability to undergo an MRI
- \- Unable to engage with study procedures in which Co-Participant input is needed.
Who the study is looking for
- 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.
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Brain Stimulation Lab Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.