Study of the WAVEWRITER ALPHA Device for Treating Chronic Neck and Upper Limb Pain Using Different Spinal Cord Stimulation Modes

What this Trial Is About

This research investigates the use of multimodal medullary stimulation to manage chronic neck and upper limb pain in patients who have not responded to other treatments. The study is randomized and prospective, aiming to assess different stimulation modes delivered by the WAVEWRITER ALPHA system to reduce pain and improve patient satisfaction. Participants will receive an implant of the WAVEWRITER ALPHA device, which delivers electrical stimulation to the spinal cord. The study evaluates five stimulation modes tonic low frequency, burst stimulation, high frequency 1000 Hz, combined tonic plus burst, and combined tonic plus high frequency. The order of these stimulation programs will be randomly assigned to each patient to compare their effects. Throughout the study, which lasts up to 34 months with individual follow-up between 7 to 10 months, patients will be monitored for pain reduction, satisfaction with stimulation, quality of life changes, and analgesic use. Researchers will also assess device recharge frequency and overall comfort with each mode. Safety and adherence will be tracked during scheduled visits and assessments.

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