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

NCT07154056 | Recruiting DMC

• 1 other identifier: 2025-A00462-47
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.

  The Multidimensional Clinical Response Indexwas previously developed and validated to evaluate the pain-related health state of PSPS-T2 patients. This weighted composite outcome includes pain intensity, functional disability, quality of life, psychological distress and pain mapping surface. The Multidimensional Clinical Response Indexis a score that ranges from 0 (worst pain-related health status) to 10 (best pain-related health status). The score has been used in several studies evaluating efficacy of different neurostimulation modalities.

  6 months

Secondary Outcomes (13)

• Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.

  6 months

• Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.

  6 months

• To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms.

  6 months

• Surface (cm²) of each symptom calculated using the Pain mapping software.

  6 months

• To characterize the Spinal Transforaminal NeuroStimulation neural targeting based on 3D-imaging and electrophysiological exploration in order to precisely identify the optimal paresthesia-based neural target locations.

  6 months

Study Arms (1)

Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation

EXPERIMENTAL

One or two 8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. This will be followed by a trial phase for a period of 7 days in order to assess the benefits of stimulation. Patients who succeeded the trial phase (at least 30% reduction of leg pain measured with a 5-day pain diary) will be implanted with a permanent system (Implantable Pulse Generator). At first, all patients will be programmed under FAST stimulation for at least 24h to fully perceive its efficacy. If the patient is satisfied with FAST then the patient will continue with this program but if the patient is not satisfied, then the patient could switch to other waveforms that will be pre-programmed during the visit including conventional and microburst stimulation.

Device: Lead(s) and Implantable Pulse Generator implantation

Interventions

Lead(s) and Implantable Pulse Generator implantation DEVICE

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.

Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has ≥ 18 years and ≤ 80 years
• Subject has a global Visual Analogic Scale ≥ 5
• Subject has non-cancer pain with a significant neuropathic component for at least 6 months.
• Subject has stable pain for at least 30 days
• Pain medication(s) dosage(s) is/are stable for at least 30 days
• Subject is eligible for Spinal Transforaminal NeuroStimulation after a pre-implantation assessment by a multidisciplinary team, as described by the French National Authority for Health (Haute Autorité de Santé)
• Subject understands and accepts the constraints of the study and is able to use the equipment.
• Patient is covered by French national health insurance.
• Subject has given written consent to the study after having received clear and complete information.
• Subject has a coagulation disorder
• Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system
• Subject has had corticosteroid therapy within the past 30 days
• Subject has had radiofrequency therapy within the past 3 months
• Subject has been diagnosed with cancer in the past 2 years
• Subject has had a spinal surgery within the past 6 months

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, France, 86000, France

RECRUITING

Central Study Contacts

Philippe Rigoard, MD, PhD

CONTACT

+33549443548; philippe.rigoard@chu-poitiers.fr

Manuel ROULAUD, MS, PhD

CONTACT

+33549443223; manuel.roulaud@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: September 4, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)