Personalized SCAN Targeted Epidura… for Parkinson's (NCT06919822)
Stabilize movement reduce off periods
- Trial ID
- NCT06919822
- Official Title
- Somato-cognitive Action Network Targeted Epidural Modulation for Parkinson's Disease (STEM-PD): a Prospective Open-label Clinical Trial
- Goal
- Stabilize movement reduce off periods
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Changping Laboratory
- Study Type
- INTERVENTIONAL
- Enrollment
- 3 participants
- Conditions
- Parkinson Disease
- Interventions
- Personalized SCAN Targeted Epidural Modulation
Summary For Families
Testing whether personalized epidural stimulation of the brain's somato-cognitive action network can stabilize movement and reduce the motor fluctuations and off periods that happen despite levodopa. The treatment surgically places epidural electrodes to deliver tailored electrical pulses that modulate abnormal brain circuits involved in movement, so it is an implant-based neuromodulation designed to work alongside levodopa rather than change how the drug is processed. The study seeks people aged 40 to 75 who have had Parkinson's for at least 5 years, are Hoehn-Yahr stage 2 to 4, respond to levodopa (≥30% improvement) but still have motor fluctuations, and it excludes those with other implants like DBS, epilepsy, severe medical or psychiatric issues, or MRI contraindications.
Locations
- The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Personalized SCAN Targeted Epidural Modulation. Testing whether personalized epidural stimulation of the brain's somato-cognitive action network can stabilize movement and reduce the motor fluctuations and off periods that happen despite levodopa. The treatment surgically places epidural electrodes to deliver tailored electrical pulses that modulate abnormal brain circuits involved in movement, so it is an implant-based neuromodulation designed to work alongside levodopa rather than change how the drug is processed. The study seeks people aged 40 to 75 who have had Parkinson's for at least 5 years, are Hoehn-Yahr stage 2 to 4, respond to levodopa (≥30% improvement) but still have motor fluctuations, and it excludes those with other implants like DBS, epilepsy, severe medical or psychiatric issues, or MRI contraindications.
- Who can participate?
- Participants must be between 40 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- Participants who show ≥30% improvement must undergo a mandatory washout period of 1-3 months and completely stop all neuromodulation therapies while keeping their PD medications stable.