Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06291051

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

Led by University Hospital, Rouen · Updated on 2026-02-17

6

Participants Needed

4

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Adult with social security affiliation who has read and signed the consent form
  • Women of childbearing age using effective contraception for 1 month before inclusion and during the study, with negative urine pregnancy test at inclusion
  • Women postmenopausal as defined by absence of periods for 12 months without other medical cause or confirmed by elevated FSH if applicable
Not Eligible

You will not qualify if you...

  • 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 treated 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 in the lower limbs
  • Pregnant, breastfeeding, or not using contraception if of childbearing potential
  • Person deprived of liberty or under judicial protection, guardianship, or curatorship
  • History of illness or psychological or sensory abnormality preventing informed consent or full participation

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Chu Amiens

Amiens, France, 80054

Actively Recruiting

2

CHU CAEN

Caen, France, 14033

Actively Recruiting

3

Chu Lille

Lille, France, 59037

Actively Recruiting

4

Chu Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

S

Stéphane Derrey, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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