RecruitingNot ApplicableNCT05398003

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

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


Sponsor

Nantes University Hospital

Enrollment

12 participants

Start Date

Nov 23, 2022

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Implantation of the WAVEWRITER ALPHA ™ device for people with pain, intractable. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation 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

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NCT05398003


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