Actively Recruiting
Prospective Single-Arm Study Evaluating Spinal Transforaminal NeuroStimulation (STNS) with FAST and MULTIWAVE in Patients with Refractory Chronic Neuropathic Pain
Led by Poitiers University Hospital · Updated on 2026-02-17
17
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Spinal Transforaminal NeuroStimulation (STNS) using FAST and MULTIWAVE stimulation to relieve neuropathic peripheral pain in people with chronic neuropathic pain. The study aims to demonstrate the effectiveness of these low-risk, low-energy treatments in patients who have not found relief with other methods. Participants will have one or two 8-contact leads placed near the spinal foramen under awake anesthesia to optimize nerve coverage. After this, they will undergo a 7-day trial phase to assess pain relief. Those with at least a 30% reduction in leg pain during this phase will receive a permanent implantable pulse generator. Initially, all patients will use FAST stimulation for at least 24 hours, and if unsatisfied, they may switch to other programmed waveforms including conventional and microburst stimulation. During the study, participants will be monitored for changes in pain intensity, health-related quality of life, functional ability, anxiety, depression, and patient satisfaction at 1, 3, and 6 months after implantation. Researchers will also evaluate neural targeting with imaging and electrophysiological tests and track any device-related events. The primary outcome is the change in the Multidimensional Clinical Response Index at 6 months.
CONDITIONS
Brief Title
Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Global Visual Analogic Scale pain score of 5 or higher
- Non-cancer neuropathic pain lasting at least 6 months
- Stable pain for at least 30 days
- Stable pain medication doses for at least 30 days
- Eligible for Spinal Transforaminal NeuroStimulation after multidisciplinary assessment
- Able to understand and use study equipment
- Covered by French national health insurance
- Provided written informed consent
You will not qualify if you...
- Coagulation disorders
- Previous treatment with spinal cord stimulation, subcutaneous or peripheral nerve stimulation, or intrathecal drug delivery system
- Corticosteroid therapy within the past 30 days
- Radiofrequency therapy within the past 3 months
- Cancer diagnosis within the past 2 years
- Spinal surgery within the past 6 months
- Participation in other interventional studies that may interfere
- Contraindications to brain MRI or implanted devices incompatible with MRI
- Subjects requiring special protection such as minors, legal protection, or emergency patients
- Pregnant or breastfeeding women, or women not using effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants will have one or two 8-contact leads positioned within the spinal foramen under awake anesthesia to optimize paresthesia coverage. This is followed by a trial phase lasting 7 days to assess the benefits of stimulation.
1 implantation visit and 1 week of trial phase monitoring
Duration - Up to 6 months
Participants who succeed the trial phase receive a permanent implant. They are initially programmed with FAST stimulation for at least 24 hours to evaluate efficacy, then may continue with FAST or switch to other pre-programmed waveforms based on satisfaction.
Follow-up visits at 1, 3, and 6 months post-implantation
Trial Site Locations
Total: 1 location
1
Poitiers University Hospital
Poitiers, France, France, 86000
Actively Recruiting
Research Team
P
Philippe Rigoard, MD, PhD
M
Manuel ROULAUD, MS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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