Recruiting
Phase 1
Phase 2

rTMS

Sponsor:

Medical University of South Carolina

Code:

NCT07113067

Conditions

Apathy

Stroke

Stroke Sequelae

Stroke/Brain Attack

Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active)

MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham)

Brainsight Neuronavigation System

Study Details

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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

Conditions

Apathy

Stroke

Stroke Sequelae

Stroke/Brain Attack

Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)

Study ID

NCT07113067

Start date

Aug 8, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active TMS

This group will receive active accelereated iTBS-rTMS

sham comparator: Sham TMS

This group will receive sham accelerated iTBS-rTMS

Interventions

MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active)

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)

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

A brainsight neuronavigation system will be used during TMS treatments to target treatment location using individual MRI data

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 ]
  • Change in apathy symptoms as measured by the Apathy Evaluation Scale (AES) - Self and Informant Versions [ Time Frame: Pre-treatment, immediately post-treatment, and weekly for four weeks post-treatment. ]
  • Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by change in the Review of Systems Criteria compared to baseline [ Time Frame: After each session of rTMS during each of six treatment days within two weeks ]
  • Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baseline [ Time Frame: Pre-treatment, immediately post-treatmen ]
  • Participant retention rate [ Time Frame: calculated at the end of the study follow-up assessment period (one month post-treatment) ]
  • Patient perception of treatment acceptability as assessed by study-specific questionnaire [ Time Frame: After each session of rTMS during each of three treatment days within one week, and at one month post-treatment follow-up ]
  • Frontal Systems Behavior Scale (FrSBE)-Apathy scale [ Time Frame: Pre-treatment, post-treatment and at 4 weeks post treatment ]

Central Contacts and Locations

Central contacts

Parneet Grewal, MD

843-792-3020grewalp@musc.edu

Lisa McTeague, PhD

843-792-8274mcteague@musc.edu

Locations

Medical University of South Carolina Brain Stimulation Lab

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Lisa McTeague, PhD

843-792-8274mcteague@musc.edu

Parneet Grewal, MD

843-792-3020grewalp@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Depression
  • Stroke
  • Stroke Recovery
  • Apathy
  • TMS
  • Motivation
  • Abulia
  • Amotivation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-08.