NCT07154056

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Lead(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.

Timeline

• Start date: 2026-02-10
• Primary completion: 2027-02-10
• Completion: 2027-10-10
• First posted: 2025-09-04
• Last updated: 2026-02-17

Locations

1 site across 1 country: France