Actively Recruiting
SCAN Targeted Epidural Modulation for Parkinson's Disease
Led by Changping Laboratory · Updated on 2026-02-19
3
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
C
Changping Laboratory
Lead Sponsor
F
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SCAN Targeted Epidural Modulation for Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic Parkinson's disease according to established diagnostic criteria.
- Age between 40 and 75 years at diagnosis.
- Any gender.
- Hoehn-Yahr stage between 2 and 4 inclusive.
- Disease duration of 5 years or more.
- At least 30% improvement in motor symptoms with levodopa in the levodopa loading test.
- Presence of motor fluctuations despite optimal drug treatment.
- Stable medication regimen for at least 1 month before screening and surgery.
- Ability to understand the trial and provide informed consent.
You will not qualify if you...
- Diagnosis of Parkinsonian superimposed syndrome or secondary Parkinson's disease.
- Brain abnormalities interfering with TMS or surgery found on MRI or CT.
- Presence of metallic medical implants affecting MRI or TMS.
- Contraindications to MRI, such as claustrophobia or metal implants.
- History of epilepsy or first-degree relatives with epilepsy.
- Received neuromodulation treatments within 1 month prior to enrollment.
- Contraindications to neurosurgery like bleeding or coagulation disorders.
- Severe organic diseases including heart failure, renal failure, or cancer.
- Cognitive impairment with MMSE score 24 or below.
- Significant speech, hearing, or vision impairments limiting testing cooperation.
- Severe depression or anxiety by clinical scores.
- Diagnosed psychiatric disorders or psychological issues interfering with the study.
- Alcohol or substance abuse.
- Active infections such as hepatitis B, hepatitis C, syphilis, or HIV.
- Other medical issues deemed unsuitable by investigators.
- Inability to complete follow-up visits due to location or other reasons.
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
- Concurrent participation in other clinical trials.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
H
Hesheng Liu, PhD
CONTACT
J
Jianxun Ren, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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