RecruitingNot ApplicableNCT07154056

Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain

Prospective, Longitudinal, Single-arm Interventional Study Evaluating the Efficacy of Spinal Transforaminal NeuroStimulation (STNS) With FAST and MULTIWAVE Stimulation in Patients With Refractory Chronic Neuropathic Pain

Sponsor

Poitiers University Hospital

Enrollment

17 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Neuropathic Pain

Summary

The goal of the study is to demonstrate Spinal Transforaminal NeuroStimulation effectiveness with FAST and other waveforms / combinations to relief neuropathic peripheral pain in chronic neuropathic pain patients, at low risk and low energy consumption.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Lead(s) and Implantable Pulse Generator implantation for people with chronic neuropathic pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

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

DEVICELead(s) and Implantable Pulse Generator implantation

8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. Awake anesthesia will allow patients to be tested during the surgery in order to determine the sweet spot and the optimal paresthesia coverage using the PREDI-P platform for a single lead. A trial phase will be performed for a period of 7 days in order to assess the benefits of stimulation according to the HAS (French Health Authority) guidelines. Subjects who succeed the lead trial will receive a permanent implant depending on the patient electrical consumption during the lead trial period or according to the implanter decision.