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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.