Electrical spinal cord stimulation for Parkinson's (NCT06291051)
Reduce camptocormia pain with stimulation
- Trial ID
- NCT06291051
- Official Title
- Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia
- Goal
- Reduce camptocormia pain with stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Rouen
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease
- Interventions
- Electrical spinal cord stimulation
Summary For Families
The goal is to see if spinal cord stimulation can be used safely to reduce the painful forward‑bending posture called camptocormia in people with Parkinson's. The approach is to implant an epidural electrode that delivers mild electrical pulses to the dorsal spinal cord to blunt pain signals and possibly alter spinal sensory‑motor circuits that affect posture, it focuses on safety of implantation and stimulation and does not change how levodopa works, so participants should stay on stable Parkinson medications. Adults with Parkinson's per UKPDSBB who have painful camptocormia of recent onset or recent worsening (total angle ≥30 degrees or greater angle ≥45 degrees), pain ≥4/10, and stable antiparkinsonian and co-analgesic treatment for 4 weeks may be eligible; people with DBS, pacemakers, major cognitive or psychiatric problems, uncontrolled medical issues, MRI or epidural contraindications, or pregnancy are excluded.
Locations
- Chu Amiens, Amiens, France
- CHU CAEN, Caen, France
- Chu Lille, Lille, France
- Chu Rouen, Rouen, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Electrical spinal cord stimulation. The goal is to see if spinal cord stimulation can be used safely to reduce the painful forward‑bending posture called camptocormia in people with Parkinson's. The approach is to implant an epidural electrode that delivers mild electrical pulses to the dorsal spinal cord to blunt pain signals and possibly alter spinal sensory‑motor circuits that affect posture, it focuses on safety of implantation and stimulation and does not change how levodopa works, so participants should stay on stable Parkinson medications. Adults with Parkinson's per UKPDSBB who have painful camptocormia of recent onset or recent worsening (total angle ≥30 degrees or greater angle ≥45 degrees), pain ≥4/10, and stable antiparkinsonian and co-analgesic treatment for 4 weeks may be eligible; people with DBS, pacemakers, major cognitive or psychiatric problems, uncontrolled medical issues, MRI or epidural contraindications, or pregnancy are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- 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 3 years and 2 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: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.