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RECRUITING
NCT05398003
NA

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

Official title: Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2022-11-23

Completion Date

2026-09-23

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

DEVICE

Implantation of the WAVEWRITER ALPHA ™ device

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)

CHU de Nantes

Nantes, France