NCT06919822

SCAN Targeted Epidural Modulation for Parkinson's Disease

Somato-cognitive Action Network Targeted Epidural Modulation for Parkinson's Disease (STEM-PD): a Prospective Open-label Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: This is a prospective, open-label, single-center clinical trial investigating the efficacy and safety of personalized epidural modulation targeting the Somato-Cognitive Action Network (SCAN) in patients with idiopathic Parkinson's disease (PD). The study employs a two-stage intervention approach with comprehensive clinical and functional assessments. The study builds upon recent discoveries that the SCAN network shows preferential connectivity with PD-affected subcortical structures. By combining advanced neuroimaging for personalized target identification with staged therapeutic intervention, the trial aims to establish proof-of-concept for this novel neuromodulation approach. The design allows for initial non-invasive validation of target engagement through iTBS before proceeding to surgical implantation. Study Design and Methodology: The trial consists of two sequential stages: \- Screening and iTBS Intervention Stage (7 days) and a Washout Period (1-3 months): Eligible participants will first undergo intermittent theta-burst stimulation (iTBS) to their individualized SCAN target, identified through resting-state functional MRI and personalized-Brain-Functional-Sector (pBFS) mapping. Participants demonstrating ≥30% improvement in motor symptoms proceed to a mandatory washout period. Complete cessation of all neuromodulation therapies while maintaining stable PD medications. \- Surgical Intervention and Follow-up (12 months): Responsive patients undergo epidural electrode implantation over their predetermined SCAN target. A scheduled12 months follow-up.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-09-01
• Completion: 2027-05-01
• First posted: 2025-04-09
• Last updated: 2026-02-19

Locations

1 site across 1 country: China