NCT07154056 Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain
| NCT ID | NCT07154056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Chronic Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2027-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2026-02-10 with a primary completion date of 2027-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07154056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154056 currently recruiting?
Yes, NCT07154056 is actively recruiting participants. Contact the research team at philippe.rigoard@chu-poitiers.fr for enrollment information.
Where is the NCT07154056 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT07154056 clinical trial?
NCT07154056 is sponsored by Poitiers University Hospital. The trial plans to enroll 17 participants.