Clinical trial NCT06919822: SCAN Electrical Stimulation for Parkinson's Disease
Official title: SCAN Electrical Stimulation for Idiopathic Parkinson's Disease: A Prospective Open-Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2025-04-09
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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 4 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 3 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.

Primary outcomes:
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III motor scores at 3 months post-stimulation（medication "off" state）
timeFrame: Baseline to 3 months post-stimulation
Secondary outcomes:
measure: Change in MDS-UPDRS-III scores (ON/OFF states) from baseline to 12 months
timeFrame: Baseline, 1-week, 1/3/6/9/12 months post-stimulation
measure: Change in daily OFF time duration (hours) from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in daily ON time duration (hours) without dyskinesia
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in 39-item Parkinson's Disease Questionnaire summary index score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Clinical Global Impression (CGI) score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in levodopa equivalent daily dose (LEDD) from baseline
timeFrame: Baseline, 3/6/9/12 months post-stimulation
Other outcomes:
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I (MDS-UPDRS-I) scores from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part II (MDS-UPDRS-I) scores from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part IV (MDS-UPDRS-I) scores from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Non-Motor Symptoms Scale (NMSS) score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Hamilton Anxiety Rating Scale (HAMA) score from baseline
timeFrame: Baseline, 1/3/6/9/12 months post-stimulation
measure: Change in Mini-Mental State Examination (MMSE) score from baseline
timeFrame: Baseline, 3/12 months post-stimulation
measure: Change in Montreal Cognitive Assessment (MoCA) score from baseline
timeFrame: Baseline, 3/12 months post-stimulation
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Changping Laboratory
name: Hesheng Liu, PhD
role: STUDY_CHAIR
References: