Accelerated rTMS vs. Sham for Stroke Apathy

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07113067
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Abulia
  • Apathy
  • Motivation
  • Stroke
  • Stroke Sequelae
  • Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)
  • Stroke/Brain Attack

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active) — DEVICE
    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.
  • MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham) — DEVICE
    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.
  • Brainsight Neuronavigation System — OTHER
    A brainsight neuronavigation system will be used during TMS treatments to target treatment location using individual MRI data

Study Details

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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

Key Dates

Start date
Aug 8, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active TMS
    This group will receive active accelereated iTBS-rTMS
  • Sham Comparator: Sham TMS
    This group will receive sham accelerated iTBS-rTMS

Primary Outcome Measure

Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baseline [ Time Frame: Pre-treatment, immediately post-treatment, and at one month post-treatment follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South Carolina Brain Stimulation LabCharlestonSouth Carolina29403
Lisa McTeague, PhD
[email protected]
843-792-8274
Parneet Grewal, MD
[email protected]
843-792-3020

Find similar trials in Charleston, SC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Medical University of South Carolina Brain Stimulation Lab· Charleston, SC

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