NCT06919822 SCAN Targeted Epidural Modulation for Parkinson's Disease
| NCT ID | NCT06919822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changping Laboratory |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2025-12-08 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hesheng Liu, PhD
STUDY CHAIR
Changping Laboratory
Frequently Asked Questions
Who can join the NCT06919822 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919822 currently recruiting?
Yes, NCT06919822 is actively recruiting participants. Contact the research team at liuhesheng@cpl.ac.cn for enrollment information.
Where is the NCT06919822 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06919822 clinical trial?
NCT06919822 is sponsored by Changping Laboratory. The principal investigator is Hesheng Liu, PhD at Changping Laboratory. The trial plans to enroll 3 participants.
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