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Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)

RecruitingNAAges 18 Years - 85 YearsAllNantes University Hospital
NCT05398003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Implantation of the WAVEWRITER ALPHA ™ device
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Where

1 site
CHU de Nantes
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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