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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
South Carolina
Medical University of South Carolina Brain Stimulation Lab
RECRUITING
Charleston
Contact Information
Primary
Parneet Grewal, MD
grewalp@musc.edu
843-792-3020
Backup
Lisa McTeague, PhD
mcteague@musc.edu
843-792-8274
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Active TMS
This group will receive active accelereated iTBS-rTMS
Sham_comparator: Sham TMS
This group will receive sham accelerated iTBS-rTMS
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov