Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Medical University of South Carolina
Summary
The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).
Description
Dementia occurs in 80% of people with Parkinson's disease (PD) within 20 years of diagnosis. Cognitive interventions in PD have centered on individuals with mild cognitive impairment (PD-MCI). A lack of efficacy of pharmacological interventions in PD-MCI has driven interest in nonpharmacological approaches. The most promising of these is intermittent theta burst stimulation (iTBS), a noninvasive brain stimulation method that is FDA-approved for several psychiatric conditions. Though iTBS has shown little to no benefit in PD-MCI thus far, there are modifiable issues with past interventions incl…
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 50-85 years of age * Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria * Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist * Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment) * Has a caregiver willing and able to reliably complete a questionnaire focused…
Interventions
- DeviceAccelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold. Each participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses/session), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention.
Location
- Medical University of South CarolinaCharleston, South Carolina