Accelerated rTMS treatment for apathy after stroke
Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement
This study is testing a new, faster treatment using brain stimulation to see if it can help stroke survivors who feel unmotivated and apathetic.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05878457 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex in individuals with chronic stroke experiencing apathy. The study utilizes a novel approach of delivering a full treatment course within a single week, as opposed to the traditional six-week regimen. Apathy, characterized by a lack of motivation and decreased goal-directed activity, significantly impacts quality of life and rehabilitation outcomes for stroke survivors. The study aims to provide a potential new treatment option for this underserved symptom, as there are currently no FDA-approved therapies specifically targeting apathy.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who have experienced a right- or left-hemisphere ischemic or hemorrhagic stroke at least six months prior and exhibit symptoms of apathy.
Not a fit: Patients with primary extra-axial hemorrhage, concomitant neurological disorders affecting cognitive function, or severe global aphasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motivation and quality of life for stroke survivors suffering from apathy.
How similar studies have performed: While traditional rTMS has been established for other psychiatric conditions, this accelerated approach targeting apathy in stroke patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 (AES) of ≥39 as rated by the participant or caregiver informant 4. Intact cortex under the coil at the stimulation target site confirmed by neuroimaging 5. Ability to participate in psychometric testing and cognitive tasks Exclusion Criteria: 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 pacemakers, 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 the 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) or suicide attempt in the previous year
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Brain Stimulation Lab — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Parneet Grewal, MD — Medical University of South Carolina
- Study coordinator: Lisa McTeague, PhD
- Email: mcteague@musc.edu
- Phone: 843-792-8274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.