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Testing stimulation of a brain network involved in action

Researchers study whether stimulation delivered outside the brain’s protective covering affects movement symptoms in Parkinson’s.

Testing a treatment or activity · Study reference: NCT06919822

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2025-12-08
Main measurements finished (planned)
2026-09
Study finished (planned)
2027-05

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Inability to complete follow-up visits due to geographical or other reasons. * Women of childbearing age who are pregnant, breastfeeding, or intend to become pregnant during the trial. * Participation in other clinical trials concurrently.
Full study name & original research details

Official study title

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

Short title used by the registry

SCAN Targeted Epidural Modulation for Parkinson's Disease

Original description

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.

Further description from the registry

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Personalized SCAN Targeted Epidural Modulation
Phases
NA
Sponsor
Changping Laboratory
Start date reported by registry
2025-12-08 (actual)

Registry updated: 2026-02-19 · Status last verified by the registry submitter: 2025-11

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Hesheng Liu, PhD · +86 13263297367 · liuhesheng@cpl.ac.cn

Jianxun Ren, PhD · +86 18813001989 · jianxun.ren@cpl.ac.cn

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Recruiting

Feng Wang · 15005018772 · 15005018772@163.com

Yuanxiang Lin, MD

Facility not reported

China

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.