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SCAN Targeted Epidural Modulation for Parkinson's Disease
Sponsor: Changping Laboratory
Summary
The goal of this clinical trial is to learn if epidural modulation targeting the Somato-Cognitive Action Network (SCAN) can improve motor symptoms in adults with idiopathic Parkinson's disease (PD). It will also evaluate the safety of this treatment. The main questions it aims to answer are: * Does epidural modulation targeting SCAN reduce motor symptoms (measured by MDS-UPDRS-III scores) in PD patients after 3 months? * Is SCAN targeted epidural modulation (STEM) a safe and tolerable treatment for PD, with minimal adverse effects? Researchers will compare participants' baseline motor function to their post-treatment results to determine if STEM is effective. Participants will: * First undergo non-invasive brain stimulation (iTBS) to test responsiveness. * If eligible, receive surgical implantation of STEM electrodes in the personalized SCAN target. * Complete follow-up visits for 12 months to monitor symptoms, side effects, and quality of life.
Official title: Somato-cognitive Action Network Targeted Epidural Modulation for Parkinson's Disease (STEM-PD): a Prospective Open-label Clinical Trial
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2025-12-08
Completion Date
2027-05
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Personalized SCAN Targeted Epidural Modulation
* Stage 1: iTBS Intervention (7 days) and Washout Period (1-3 months) * All enrolled participants undergo: * Baseline clinical assessments * Structural and functional MRI with pBFS mapping * Resting motor threshold determination * Daily iTBS sessions targeting individualized SCAN coordinates: * Treatment duration: 7 consecutive days * Post-intervention evaluation at Day 7-14 * Mandatory observation window: * No neuromodulation therapies permitted * Stable PD medication regimen maintained * Monthly safety monitoring * Stage 2: Surgical Intervention and Follow-up (12 months) * Surgical Procedure: * Epidural electrode implantation * Pulse generator internalization * Epidural Modulation Stage: * Parameter optimization visits * Scheduled follow-ups at Months 1, 3, 6, 12
Locations (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China