Accelerated rTMS for Post-Stroke Apathy (NCT05878457) | Clinical Trial Compass
CompletedPhase 1
Accelerated rTMS for Post-Stroke Apathy
United States14 participantsStarted 2023-12-01
Plain-language summary
This pilot study will investigate the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC) to address apathy symptoms in individuals with chronic stroke.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 (AES) of ≥39 as rated by the participant or caregiver informant
✓. Intact cortex under the coil at the stimulation target site confirmed by neuroimaging
✓. Ability to participate in psychometric testing and cognitive tasks
Exclusion criteria
✕. Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
✕. Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
✕. Moderate or severe global aphasia
✕. Visual impairment precluding completion of cognitive tasks
✕. 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;
✕. Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
✕. History of a seizure disorder
What they're measuring
1
Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baseline
Timeframe: Pre-treatment, immediately post-treatment, and weekly for four weeks post-treatment
2
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by change in the Review of Systems Criteria compared to baseline
Timeframe: After each session of rTMS during each of three treatment days within one week
3
Change in global cognition, as measured by the Montreal Cognitive Assessment (MoCA) compared to baseline
Timeframe: Pre-treatment, immediately post-treatment, and at one month post-treatment follow-up
4
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baseline