Accelerated rTMS vs. Sham for Stroke Apathy
Accelerated rTMS for Post-stroke Apathy: A Double-blind Randomized Controlled Trial
Medical University of South Carolina
40 participants
Aug 8, 2025
INTERVENTIONAL
Conditions
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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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
Inclusion Criteria8
- 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.
Exclusion Criteria15
- 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:
- \- Unable to engage with study procedures in which Co-Participant input is needed.
Interventions
Active treatment will consist of high-dose iTBS-rTMS to left dmPFC delivered in runs of 600 pulses at an intensity of 120% resting motor threshold (rMT). iTBS triplets at 50 Hz will be delivered for 2 seconds, repeated every 10 seconds for a total of 190 seconds. Each session will be separated by at least 10-15 minutes and a total of 12 sessions will be given on each treatment day (3-4 hours per study day). A total of 43,200 pulses will be delivered over the entire six days of treatment.
For the sham stimulation group, a focal electric sham will be used which is indistinguishable from active TMS including a pretreatment individualized sham titration, sham outputs noises synchronized to pulse delivery, and an individualized level of sham stimulation throughout the treatment. Technicians administering active vs sham TMS will be masked by using a random code generated by the statistician that will indicate whether to use the active or sham side of the coil. Treatments will appear identical to the technician regardless of whether active or sham TMS is administered.
A brainsight neuronavigation system will be used during TMS treatments to target treatment location using individual MRI data
Locations(1)
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NCT07113067