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

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosed with idiopathic Parkinson's disease (PD) according to the revised clinical diagnostic criteria of the International Movement Disorder Society (MDS) (2015 version) or the Chinese Parkinson's Disease Diagnostic Criteria (2016 version).

• Age between 40 and 75 years, with a minimum age of 40 years at the time of diagnosis.

• Any gender, including both male and female patients.

• Hoehn-Yahr staging between 2 and 4 (inclusive).

• Disease duration of 5 years or more.

• Responding effectively to levodopa-based drug therapy with a minimum of 30% improvement in the levodopa loading test.

• Presence of motor fluctuations with or without anisocoria despite optimal drug treatment.

• Stable on medication for at least the past 1 month prior to screening and surgery.

• Ability to understand the trial and willingness to sign an informed consent form.

Locations
Other Locations
China
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
Hesheng Liu, PhD
liuhesheng@cpl.ac.cn
+86 13263297367
Backup
Jianxun Ren, PhD
jianxun.ren@cpl.ac.cn
+86 18813001989
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2027-05
Participants
Target number of participants: 3
Treatments
Experimental: Personalized STEM Intervention Arm
This experimental arm involves a comprehensive two-stage therapeutic intervention for Parkinson's disease patients:~* Pre-surgical Screening Stage:~ * All participants first undergo non-invasive intermittent theta-burst stimulation (iTBS) targeting their individualized Somato-Cognitive Action Network (SCAN) region.~* Surgical Intervention Stage (for iTBS responders):~ * Patients showing ≥30% improvement in motor symptoms proceed to epidural implantation of electrodes over the predetermined SCAN target.
Related Therapeutic Areas
Sponsors
Leads: Changping Laboratory
Collaborators: First Affiliated Hospital of Fujian Medical University

This content was sourced from clinicaltrials.gov