Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Recruiting now · Not applicable
Conditions studied: Pain, Intractable
In brief
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 months Expected number of cases : 12 Treatment, procedure, combination of procedures under consideration : During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode. There will be a random draw on the order of the stimulation program: * the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias * burst stimulation (or "burst") * high frequency" stimulation (1000 Hz) "High frequency: HF". * combined tonic + burst stimulation * combined tonic + high frequency stimulation
Key facts
- Study ID
- NCT05398003
- Run by
- Nantes University Hospital
- People needed
- 12
- Starts
- 2022-11-23
- Expected to finish
- 2026-09-23
- Last updated by the study team
- 2024-11-18
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 7-day post-implantation test phase negative
Where it is running
- CHU de Nantes — Nantes, France (enrolling)
Full record on ClinicalTrials.gov
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