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

Plain-Language Summary

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.

View on ClinicalTrials.gov