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?
- 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 3 years and 2 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.