Spinal transforaminal neurostimulation with FAST and MultiWave for 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

This trial will test whether spinal transforaminal neurostimulation using FAST and MultiWave waveforms can reduce long-standing neuropathic peripheral pain in adults whose pain has not responded to other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Poitiers University Hospital (other)
• Locations: 1 site (Poitiers, France)
• Trial ID: NCT07154056 on ClinicalTrials.gov

What this trial studies

The study implants transforaminal leads and an implantable pulse generator (IPG) to deliver FAST and MultiWave stimulation patterns aimed at relieving chronic neuropathic peripheral pain. Eligible adults (18–80 years) must have at least 6 months of neuropathic pain, a baseline VAS ≥5, stable pain and medication regimens, and pass a multidisciplinary pre-implant assessment per French National Authority for Health guidance. After implantation, patients are followed to measure changes in pain intensity, device energy consumption, and safety/tolerability. The protocol emphasizes low-energy settings and selection criteria to minimize procedural risk.

Who should consider this trial

Good fit: Adults aged 18–80 with non-cancer neuropathic peripheral pain for at least 6 months, a VAS of 5 or higher, stable pain and medication for 30 days, eligibility for spinal transforaminal neurostimulation per French guidance, and coverage by French national health insurance are ideal candidates.

Not a fit: People with coagulation disorders, prior spinal cord/subcutaneous/peripheral nerve stimulation or intrathecal drug delivery systems, cancer-related pain, or those who are not candidates for implantation are unlikely to be helped or are excluded.

Why it matters

Potential benefit: If successful, this approach could give people with refractory neuropathic pain better pain relief with lower energy use and a lower procedural risk profile compared with some existing options.

How similar studies have performed: Related neuromodulation methods such as spinal cord stimulation and peripheral nerve stimulation have demonstrated pain relief in neuropathic pain, but STNS with FAST/MultiWave is relatively novel with limited published outcome data.

Eligibility criteria

Inclusion Criteria:

* 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.

Non-inclusion Criteria:

* 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
* Simultaneous participation to any interventional study on health product or any study able to interfere with the current study endpoints.
* Subject has at least one of brain MRI contraindications such as : intracranial clips /Vascular clips/Pace maker/Heart battery, Defibrillator, Implanted Holter (REVEAL type), Neuro-stimulator not compatible with 1.5 T MRI/Stents/ Coils/Cardiac valves (heart)/ Shunt valve/Implanted injection pump/Cochlear implants/Implantable chamber (PAC)/Intracorporeal metal shards/ metallic foreign bodies, the location and the presence of implanted neurostimulation components that are not listed as MRI Conditional, cardiac implantable electronic device, metallic intraocular foreign bodies, cochlear implants, drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing.
* Subjects requiring closer protection, i.e. minors, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting
* Pregnant or breastfeeding women, women at age to procreate and not using effective contraception.

Where this trial is running

Poitiers, France

• Poitiers University Hospital — Poitiers, France, France (RECRUITING)

Study contacts

• Study coordinator: Philippe Rigoard, MD, PhD

Conditions: Chronic Neuropathic Pain