The goal of this clinical trial is to learn if electrical stimulation 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 electrical stimulation targeting SCAN reduce motor symptoms (measured by MDS-UPDRS-III scores) in PD patients after 3 months? * Is SCAN electrical simulation (SES) 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 SES is effective. Participants will: * First undergo non-invasive brain stimulation (iTBS) to test responsiveness. * If eligible, receive surgical implantation of SES electrodes in the personalized SCAN target. * Complete follow-up visits for 12 months to monitor symptoms, side effects, and quality of life.
Background: This is a prospective, open-label, single-center clinical trial investigating the efficacy and safety of personalized electrical stimulation 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 (14 days) and a Washout Period (3-6 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. Includes 1-week externalized testing before pulse generator internalization. A scheduled12 months follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
* Stage 1: iTBS Intervention (14 days) and Washout Period (3-6 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: 14 consecutive days * Post-intervention evaluation at Day 14-21 * 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 * 7-day externalized stimulation testing * Pulse generator internalization * Chronic Stimulation Stage: * Parameter optimization visits * Scheduled follow-ups at Months 1, 3, 6, 9, 12
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: Baseline to 3 months post-stimulation
Change in MDS-UPDRS-III scores (ON/OFF states) from baseline to 12 months
Difference in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination scores (range 0-132, higher=worse) between baseline and post-stimulation assessments during both medication ON (2 hours after levodopa dose) and OFF (after 12-hour withdrawal) states.
Time frame: Baseline, 1-week, 1/3/6/9/12 months post-stimulation
Change in daily OFF time duration (hours) from baseline
Reduction in self-reported daily hours of OFF periods (time when Parkinson's medications are ineffective) as recorded in patient diaries, comparing baseline to post-stimulation timepoints.
Time frame: Baseline, 1/3/6/9/12 months post-stimulation
Change in daily ON time duration (hours) without dyskinesia
Increase in self-reported daily hours of good ON periods (medication effectiveness without troublesome dyskinesia) from baseline to follow-up assessments.
Time frame: Baseline, 1/3/6/9/12 months post-stimulation
Change in 39-item Parkinson's Disease Questionnaire summary index score from baseline
Difference in 39-item Parkinson's Disease Questionnaire (PDQ-39) total score (range 0-100, higher=worse quality of life) between baseline and follow-up assessments.
Time frame: Baseline, 1/3/6/9/12 months post-stimulation
Change in Clinical Global Impression (CGI) score from baseline
Improvement in clinician-rated CGI scale (range 1-7, higher=worse) assessing overall disease severity change since baseline.
Time frame: Baseline, 1/3/6/9/12 months post-stimulation
Change in levodopa equivalent daily dose (LEDD) from baseline
Reduction in calculated total daily dopaminergic medication dosage (mg/day) while maintaining symptom control.
Time frame: Baseline, 3/6/9/12 months post-stimulation
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