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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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. Subjec

Первичные конечные точки

• The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index. [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. [Срок оценки: 6 months]
• Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation. [Срок оценки: 6 months]
• To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms. [Срок оценки: 6 months]
• Surface (cm²) of each symptom calculated using the Pain mapping software. [Срок оценки: 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. [Срок оценки: 6 months]
• Rate of serious and non-serious adverse events and device deficiencies will be reported. [Срок оценки: 6 months]
• Rate of patients undergoing FAST stimulation (exclusively or in combination with other waveforms) at 6-month follow-up. [Срок оценки: 6 months]
• Mean absolute change in Multidimensional Clinical Response Index for the subgroup of patients undergoing FAST at 1-, 3- and 6-month follow-ups. [Срок оценки: 6 months]
• Absolute change in pain surface between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. [Срок оценки: 6 months]
• Absolute change in health related quality of life between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. [Срок оценки: 6 months]
• Absolute change in functional disability between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. [Срок оценки: 6 months]
• Absolute change in anxiety and depression between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Poitiers University Hospital — Poitiers

Идентификаторы

NCT: NCT07154056 · 2025-A00462-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗