Electrical spinal cord stimulation for painful camptocormia in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, safety-focused protocol implants or programs spinal cord stimulation devices to treat patients with Parkinson's disease who have painful camptocormia. Eligible participants must meet UKPDSBB diagnostic criteria for Parkinson's, have a defined camptocormia angle above protocol thresholds, recent onset or recent worsening of the posture disorder, and persistent pain (VAS ≥ 4) despite optimized medical therapy. The study requires stable antiparkinsonian and co-analgesic regimens before enrollment and follows patients after stimulation to monitor adverse events and changes in pain and posture. Primary outcomes emphasize device safety, with secondary measures tracking pain scores and objective camptocormia angles.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Amiens
  Amiens, France Recruiting
• Chu Caen
  Caen, France Recruiting
• Chu Lille
  Lille, France Recruiting
• Chu Rouen
  Rouen, France Recruiting

Study contacts

• Study coordinator: Stéphane Derrey, Pr
• Email: Stephane.Derrey@chu-rouen.fr
• Phone: 02 32 88 80 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.