💬In plain words
What the trial is, and whether it could suit you
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, resorti
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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