Status:
RECRUITING
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Lead Sponsor:
Nantes University Hospital
Conditions:
Pain, Intractable
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Number of centres planned : 1 (CHU Nantes) Design : Randomized, Prospective Planning of the study : * Total duration: 34 months * Recruitment period: 24 months. * Follow-up time per patients : 7-10...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged 18 to 85 years
- Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
- Patients must be able to give informed consent and must have signed an informed consent
- Affiliation to the health insurance
- A negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial
- Non-inclusion criteria:
- Drug or alcohol abuse
- Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)
- Difficulty with follow-up
- Pregnant or breastfeeding women
- Women of childbearing potential who are not using contraception
- Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty
- Exclusion period for another study
- Participation in another interventional study whose primary objective is based on pain.
- Exclusion criteria:
- \- 7-day post-implantation test phase negative
Exclusion
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05398003
Start Date
November 23 2022
End Date
September 23 2026
Last Update
November 18 2024
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44093