Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Ne… (NCT07154056) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain
France17 participantsStarted 2026-02-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, Def…
What they're measuring
1
The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.