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

Poitiers University Hospital

Status: Not yet enrolling

Conditions: Chronic Neuropathic Pain

Treatments: Device: Lead(s) and Implantable Pulse Generator implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07154056

2025-A00462-47

Details and patient eligibility

About

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Lead(s) and Implantable Pulse Generator implantation