Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Nantes University Hospital
12 participants
Nov 23, 2022
INTERVENTIONAL
Conditions
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 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
Eligibility
Inclusion Criteria14
- 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
- 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 Criteria1
- \- 7-day post-implantation test phase negative
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities: * tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias * high frequency" stimulation (1000 Hz) "High Frequency". * stimulation in bursts (or "Burst")
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05398003