SCAN Targeted Epidural Modulation for Parkinson's Disease

NCT06919822 | Recruiting

• 1 other identifier: STEM-PD
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III motor scores at 3 months post-stimulation（medication "off" state）

  The change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination scores measured during the medication "off" state (after 12-hour overnight withdrawal of anti-Parkinson medications) from baseline to 3 months after initiating motor cortex stimulation. Higher scores indicate more severe motor impairment (range 0-132). A negative change indicates improvement.

  Baseline to 3 months post-stimulation

Secondary Outcomes (6)

• Change in MDS-UPDRS-III scores (ON/OFF states) from baseline to 12 months

  Baseline, 1-week, 1/3/6/12 months post-stimulation

• Change in daily OFF time duration (hours) from baseline

  Baseline, 1/3/6/12 months post-stimulation

• Change in daily ON time duration (hours) from baseline

  Baseline, 1/3/6/12 months post-stimulation

• Change in 39-item Parkinson's Disease Questionnaire summary index score from baseline

  Baseline, 1/3/6/12 months post-stimulation

• Change in Clinical Global Impression (CGI) score from baseline

  Baseline, 1/3/6/12 months post-stimulation

Other Outcomes (9)

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I (MDS-UPDRS-I) scores from baseline

  Baseline, 1/3/6/12 months post-stimulation

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part II (MDS-UPDRS-II) scores from baseline

  Baseline, 1/3/6/12 months post-stimulation

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part IV (MDS-UPDRS-IV) scores from baseline

  Baseline, 1/3/6/12 months post-stimulation

Study Arms (1)

Personalized STEM Intervention Arm

EXPERIMENTAL

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.

Device: Personalized SCAN Targeted Epidural Modulation

Interventions

Personalized SCAN Targeted Epidural Modulation DEVICE

* 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

Personalized STEM Intervention Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of Parkinsonian superimposed syndrome or secondary Parkinson's disease.
• Presence of intracranial structural variants or other abnormalities that may interfere with TMS or surgical treatment, as detected by MRI or CT.
• Implantation of metallic medical devices such as deep brain stimulators, cochlear implants, vagus nerve stimulators, etc., which may affect MRI examination and TMS treatment.
• Contraindications to MRI scanning, including claustrophobia, tattoos, or magnetic metal-containing implants (to be confirmed with specialists).
• History of comorbid epilepsy or having first-degree relatives with a history of epilepsy.
• Receipt of other neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within the 1 months prior to enrollment.
• Contraindications to neurosurgery, such as bleeding or coagulation disorders.
• Presence of severe organic diseases, including heart failure, renal failure, or malignancies.
• Cognitive impairment as indicated by MMSE score of 24 or below.
• Significant speech impairment, hearing impairment, or visual impairment that limits cooperation with testing.
• Severe depression (HAMD-17 score of 24 or above) or severe anxiety (HAMA score of 29 or above).
• Diagnosed psychiatric disorders based on DSM-V criteria or any psychological issues that may interfere with the study protocol.
• Alcohol or substance abuse.
• Active infections including hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, or human immunodeficiency virus (HIV) infection as determined by the investigator.
• Any other medical abnormalities deemed by the investigator to be unsuitable for participation in the trial.

Sponsors & Collaborators

• Changping Laboratory: lead
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hesheng Liu, PhD

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Hesheng Liu, PhD

CONTACT

+86 13263297367; liuhesheng@cpl.ac.cn

Jianxun Ren, PhD

CONTACT

+86 18813001989; jianxun.ren@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2025-11

Locations

CN (1)