Actively Recruiting

Phase 1
Phase 2
Age: 40Years +
All Genders
ID07113067

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

Led by Medical University of South Carolina · Updated on 2025-10-22

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Apathy, characterized by loss of motivation and withdrawal, commonly affects many people after a stroke and significantly lowers quality of life for both patients and their caregivers. This research aims to evaluate if a fast-delivered form of repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC) can be safe, tolerable, and helpful for treating apathy following stroke. The study is a randomized, double-blind trial designed to explore efficacy, safety, and other impacts beyond apathy in stroke survivors. The trial compares two groups: one receiving active accelerated intermittent theta burst stimulation (iTBS) rTMS to the left dorsal medial prefrontal cortex (dmPFC), and the other receiving a sham version that mimics the procedure without active stimulation. Participants receive 12 sessions daily over six treatment days within two weeks, totaling 72 sessions and 43,200 pulses. Brain imaging and neuronavigation guide precise treatment delivery, and the study uses advanced devices to ensure blinding and standardized targeting. Participants will be assessed at baseline, immediately after treatment, and one month later through clinical tests, brain MRIs, and questionnaires evaluating apathy and cognition. Safety is monitored throughout each treatment day, and participant retention and treatment acceptability are tracked. Outcomes include changes in apathy symptoms, cognition, and depression, as well as any adverse events, with the total involvement spanning the treatment period plus follow-up assessments.

CONDITIONS

Brief Title

Accelerated rTMS vs. Sham for Stroke Apathy

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 years old or greater
  • Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
  • Symptomatic apathy with an Apathy Evaluation Scale score of 39 or higher
  • Ability to participate in psychometric testing and cognitive tasks
  • Intact cortex at the TMS target site confirmed by pre-treatment MRI
  • Availability of a co-participant or caregiver who meets study criteria
Not Eligible

You will not qualify if you...

  • Primary extra-axial hemorrhage without ischemic stroke or intraparenchymal hemorrhage
  • Other neurological disorders affecting motor or cognitive function (e.g., dementia)
  • Moderate or severe global aphasia
  • Visual impairment preventing completion of cognitive tasks
  • Contraindications to MRI or TMS such as metal or electronic implants
  • Pregnancy
  • History of seizure disorder
  • Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
  • Claustrophobia preventing MRI
  • Active substance use disorder
  • Psychotic disorders
  • Bipolar 1 Disorder
  • Acute suicidality or suicide attempt in the past year
  • Co-participants/caregivers unable to engage with study procedures when needed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 2 weeks

Participants receive accelerated iTBS-rTMS or sham stimulation targeting the left dmPFC using neuronavigation for 6 days over 2 weeks.

6 treatment days with 12 sessions per day (3-4 hours each day)

Follow-up

Duration - 1 month

Participants undergo clinical assessments to measure changes in apathy, cognition, and treatment acceptability after treatment completion.

Visits at immediately post-treatment and 1-month post-treatment follow-up

Trial Site Locations

Total: 1 location

1

Medical University of South Carolina Brain Stimulation Lab

Charleston, South Carolina, United States, 29403

Actively Recruiting

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Research Team

P

Parneet Grewal, MD

L

Lisa McTeague, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Demographically Corrected Normative Standards for the English Version of the NIH Toolbox Cognition Battery.

Kaitlin B Casaletto, Anya Umlauf, Jennifer Beaumont...

https://pubmed.ncbi.nlm.nih.gov/26030001

The Lille apathy rating scale (LARS), a new instrument for detecting and quantifying apathy: validation in Parkinson's disease.

P Sockeel, K Dujardin, D Devos...

https://pubmed.ncbi.nlm.nih.gov/16614016

The Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation for Improving Apathy in Chronic Stroke Patients.

Nobuyuki Sasaki, Takatoshi Hara, Naoki Yamada...

https://pubmed.ncbi.nlm.nih.gov/28578330