Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
ConditionPain, Intractable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNantes University Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Implantation of the WAVEWRITER ALPHA ™ device
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov