RECRUITING

Accelerated rTMS vs. Sham for Stroke Apathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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

Official Title

Accelerated rTMS for Post-stroke Apathy: A Double-blind Randomized Controlled Trial

Quick Facts

Study Start:2025-07-31
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07113067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 40 years old or greater
  2. * Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
  3. * Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥39
  4. * Ability to participate in psychometric testing and cognitive tasks
  5. * Intact cortex at the TMS target site as confirmed by pre-treatment MRI
  6. * Ability to have a co-participant/caregiver who meets the criteria as detailed below.
  1. * Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
  2. * Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
  3. * Moderate or severe global aphasia
  4. * Visual impairment precluding completion of cognitive tasks
  5. * 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;
  6. * Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
  7. * History of a seizure disorder
  8. * Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
  9. * Claustrophobia precluding ability to undergo an MRI
  10. * Active substance use disorder
  11. * Psychotic disorders
  12. * Bipolar 1 Disorder
  13. * Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide attempt in the previous year

Contacts and Locations

Study Contact

Parneet Grewal, MD
CONTACT
843-792-3020
grewalp@musc.edu
Lisa McTeague, PhD
CONTACT
843-792-8274
mcteague@musc.edu

Principal Investigator

Parneet Grewal, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Lisa McTeague, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Kevin Caulfield, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina Brain Stimulation Lab
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Parneet Grewal, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina
  • Lisa McTeague, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina
  • Kevin Caulfield, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-07-31
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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