Superior Parietal iTBS for PD-MCI
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT07701785
- Status
- Recruiting
Conditions
- Mild Cognitive Impairment
- Parkinson Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL) — DEVICEParticipants 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.
Study Details
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).
Key Dates
- First listed
- Jul 14, 2026
- Start date
- Aug 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Feb 1, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Accelerated iTBSParticipants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site. Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST). Stimulation for the intervention will be delivered at 120% rMT. Stimulation sessions will occur over three consecutive days. Each day will include 10 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions.
Primary Outcome Measure
Serious Adverse Events [ Time Frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 |
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