Accelerated rTMS vs. Sham for Stroke Apathy

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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

Interventions

DEVICE

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.

DEVICE

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.

OTHER

Brainsight Neuronavigation System

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

Sponsors & Collaborators

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Parneet Grewal, PhD · Medical University of South Carolina

• Lisa McTeague, PhD · Medical University of South Carolina

• Kevin Caulfield, PhD · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-08

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Device

Yes

Countries

• United States

Study Locations