--- title: Reduce camptocormia pain with stimulation nct_id: NCT06291051 phase: NA status: RECRUITING sponsor: University Hospital, Rouen study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06291051" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06291051" last_fetched: "2026-05-10T14:02:07.116Z" source: "Parkinson's Pathways (curated)" --- # Reduce camptocormia pain with stimulation **Goal (in five words):** Reduce camptocormia pain with stimulation **Official Title:** Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia **Trial ID:** [NCT06291051](https://clinicaltrials.gov/study/NCT06291051) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** University Hospital, Rouen - **Target Enrollment:** 6 participants - **Start Date:** 2025-08-01 - **Completion Date:** 2028-10-01 - **Conditions:** Parkinson Disease - **Interventions:** Electrical spinal cord stimulation - **Intervention Types:** DEVICE ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * Parkinson's disease validated according to UKPDSBB clinical criteria * Camptocormia defined by a total camptocormia angle (ACT) \> 30° or a greater camptocormia angle (ACS) \> 45° * Camptocormia established for less than 2 years or recently worsening for less than 1 year. * Persistent camptocormia despite optimal drug treatment at the time of inclusion * Pain associated with abnormal posture: VAS ≥ 4/10 during the last 3 months * Stable antiparkinsonian treatment for 4 weeks * Treatment with co-analgesics stable for 4 weeks * Criteria relating to regulation: * Major person * Affiliation to a social security scheme * Adult who has read and understood the information letter and signed the consent form * Women: * Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy)): * using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device IUD), male or female condoms) for 1 month before inclusion and during the study And, * presenting a negative urine pregnancy test at inclusion - Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause before the inclusion visit. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Exclusion Criteria: * Atypical parkinsonian syndrome * Contraindication to surgery and anesthetic products * Uncontrolled diabetes * Systemic or local infection * Major cognitive disorders: MOCA \< 25 * Severe psychosis associated with Parkinson's disease * Severe depressive syndrome: MADRS \> 35 * Patient with deep brain stimulation * Patient with a cardiac pacemaker * Patient currently being treated by diathermy or to be treated by diathermy * Severe substance use disorders (alcohol, drugs, medication) * Contraindication to MRI * Obstacle to the placement of a dorsal epidural electrode * Dorsal myelopathy * Severe associated scoliosis * Severe camptocormia defined by an ACT \> 80° * Severe alteration of somesthetic evoked potentials (ESP) in the lower limbs * Pregnant or parturient or breastfeeding woman or proven absence of contraception * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship * History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent ``` ## Locations (4) - Chu Amiens, Amiens, France _(49.9000, 2.3000)_ - Melissa Tir, Dr — (CONTACT) — 03 22 08 83 73 — tir.melissa@chu-amiens.fr - Mélissa Tir, Dr — (PRINCIPAL_INVESTIGATOR) - CHU CAEN, Caen, France _(49.1859, -0.3591)_ - Claire Thiriez, Dr — (CONTACT) — 02-31-06-52-94 — Thiriez-c@chu-caen.fr - Claire Thiriez, Dr — (PRINCIPAL_INVESTIGATOR) - Chu Lille, Lille, France _(50.6339, 3.0551)_ - Luc Defebvre, Pr — (CONTACT) — 0320446072 — luc.defebvre@chu-lille.fr - Luc Defebvre, Pr — (PRINCIPAL_INVESTIGATOR) - Chu Rouen, Rouen, France _(49.4431, 1.0993)_ - Stéphane Derrey, Pr — (CONTACT) — 02 32 88 80 42 — Stephane.Derrey@chu-rouen.fr - Stéphane Derrey, Pr — (PRINCIPAL_INVESTIGATOR) - David Maltête, Pr — (SUB_INVESTIGATOR) ## Central Contacts - Stéphane Derrey, Pr — (CONTACT) — 02 32 88 80 42 — Stephane.Derrey@chu-rouen.fr --- *Canonical: https://parkinsonspathways.com/trial/NCT06291051* *HTML version: https://parkinsonspathways.com/trial/NCT06291051* *Source data: https://clinicaltrials.gov/study/NCT06291051*