Personalized epidural stimulation of the Somato-Cognitive Action Network for Parkinson's disease

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

This project will test whether personalized epidural stimulation targeting the SCAN brain network can reduce motor symptoms in adults with idiopathic Parkinson's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06919822 on ClinicalTrials.gov

What this trial studies

This open-label, single-center study uses resting-state fMRI and personalized brain mapping to identify a SCAN target for each participant, then applies an initial noninvasive iTBS session to test responsiveness. Participants who show a predefined motor response proceed after a washout to surgical implantation of epidural electrodes placed over the personalized SCAN target. Motor outcomes (MDS-UPDRS-III) at three months and safety/tolerability are tracked, with additional clinical and quality-of-life assessments over 12 months of follow-up. The design is a proof-of-concept to determine whether network-targeted epidural modulation can produce clinically meaningful motor improvement.

Who should consider this trial

Good fit: Adults aged 40–75 with idiopathic Parkinson's disease for at least 5 years, Hoehn–Yahr stage 2–4, who respond to levodopa and have motor fluctuations despite optimized medication are the intended candidates.

Not a fit: Patients with atypical or secondary parkinsonism, poor levodopa responsiveness, severe cognitive impairment, contraindications to MRI or surgery, or inability to complete follow-up are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, SCAN-targeted epidural modulation could reduce Parkinsonian motor symptoms and improve daily function by delivering personalized network-directed stimulation.

How similar studies have performed: While various neuromodulation strategies (noninvasive stimulation, spinal/epidural approaches) have shown symptomatic effects in PD, SCAN-targeted epidural modulation is largely novel and remains an early proof-of-concept with limited prior clinical data.

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.

Where this trial is running

Fuzhou, Fujian

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Hesheng Liu, PhD

Conditions: Parkinson Disease