Condition: Pain, Intractable · Sponsor: Nantes University Hospital
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
This description comes directly from the study's public registry record.
Sylvie RAOUL · 02 40 16 50 80 · sylvie.raoul@chu-nantes.fr
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| CHU de Nantes | Nantes, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05398003