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Tests treatment safety and results for Parkinson Disease
Official title Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia
ClinicalTrials.gov ID: NCT06291051
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Caen, France
- Lille, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Caen, France; Lille, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.