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Accelerated Transcranial Magnetic Stimulation (TMS) for Apathy in Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo six treatment visits over two weeks, receiving eight iTBS sessions per day. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at two and four weeks post-treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 45-85

• Diagnosis of Parkinson's Disease

• AES ≥37

• Stable PD medications

• Caregiver informant available

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 15
Treatments
Other: TMS group
participants with Parkinson's disease and clinically significant apathy receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex (dmPFC) using a MagVenture MagPro system with a cooled figure-of-eight coil and Brainsight neuronavigation (slightly off midline). Resting motor threshold (rMT) is determined on the first stimulation visit (PEST) and stimulation is delivered at 120% rMT. Treatment occurs on 6 days over \~2 weeks (days may be non-contiguous), with 8 sessions/day separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 s), totaling 4,800 pulses/day and 28,800 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) is assessed before/after sessions.
Related Therapeutic Areas
Movement Disorders
Parkinson's Disease
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov

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