Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia (CAMPTOSTIM)

February 13, 2026 updated by: University Hospital, Rouen

Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.

Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Mélissa Tir, Dr
      • Caen, France, 14033
        • Recruiting
        • CHU Caen
        • Contact:
        • Principal Investigator:
          • Claire Thiriez, Dr
      • Lille, France, 59037
        • Recruiting
        • CHU Lille
        • Contact:
        • Principal Investigator:
          • Luc Defebvre, Pr
      • Rouen, France, 76031
        • Recruiting
        • CHU Rouen
        • Sub-Investigator:
          • David Maltête, Pr
        • Contact:
        • Principal Investigator:
          • Stéphane Derrey, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia
Device: Electrical spinal cord stimulation
electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia
Time Frame: 11 months post-operative operative
The presence of intraoperative or postoperative adverse events, including in particular short-term postoperative complications but also any adverse event observed until the end of study visit (V7) at 10 - 11 months post-operative operative approximately.
11 months post-operative operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0382/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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