Accelerated repetitive transcranial magnetic stimulation (rTMS) versus sham for post-stroke apathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double‑blind, sham‑controlled Phase 1/2 study testing an accelerated rTMS protocol targeting the dorsal medial prefrontal cortex (dmPFC)/medial prefrontal cortex using MRI‑guided neuronavigation. Participants aged 40 or older with persistent apathy after a stroke (AES ≥39) and intact cortex at the target site will receive either active or sham stimulation delivered in an accelerated schedule. The study will monitor safety, tolerability, and changes in apathy and related functional measures using standardized scales and cognitive testing. Investigators will also examine feasibility of personalized coil placement based on each participant’s post-stroke brain anatomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of South Carolina Brain Stimulation Lab
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Parneet Grewal, PhD — Medical University of South Carolina
• Study coordinator: Parneet Grewal, MD
• Email: grewalp@musc.edu
• Phone: 843-792-3020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using MEG to Evaluate Recovery After Minor Stroke

  This study is testing how well people recover their thinking skills after a minor stroke by using special brain scans at 1 and 6 months after the stroke.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT04188522

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Wrist-worn device to encourage use of the weaker arm after a recent stroke

  This trial tests whether a wrist-worn sensor system plus motor and behavioral home coaching helps people 1–6 months after a stroke with moderate arm weakness use their affected arm more than a usual home-exercise program.

  Recruiting Spaulding Rehabilitation Hospital · Boston, Massachusetts · NCT06797154

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• Trans-spinal magnetic stimulation for improving mobility in chronic stroke patients

  This study is testing if a new type of magnetic treatment can help improve walking and movement in adults who have had a stroke for a long time.

  Recruiting at 3 sites Universidade Federal de Pernambuco · João Pessoa, Paraíba and 2 other locations · NCT06593184

• Telehealth program for lifestyle changes in stroke survivors

  This study tests whether a telehealth program can help stroke survivors make healthy lifestyle changes with support from others over six months.

  Recruiting Baylor Research Institute · Dallas, Texas · NCT06569121

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.