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SCAN Targeted Epidural Modulation for Parkinson's Disease

NCT06919822 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Changping Laboratory

    lead OTHER

Principal Investigators

  • Hesheng Liu, PhD · Changping Laboratory

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-09-30
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06919822 on ClinicalTrials.gov