Actively Recruiting
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Led by Nantes University Hospital · Updated on 2024-11-18
12
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Number of centres planned : 1 (CHU Nantes) Design : Randomized, Prospective Planning of the study : * Total duration: 34 months * Recruitment period: 24 months. * Follow-up time per patients : 7-10 months Expected number of cases : 12 Treatment, procedure, combination of procedures under consideration : During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode. There will be a random draw on the order of the stimulation program: * the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias * burst stimulation (or "burst") * high frequency" stimulation (1000 Hz) "High frequency: HF". * combined tonic + burst stimulation * combined tonic + high frequency stimulation
CONDITIONS
Official Title
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 85 years
- Patients with chronic neck and upper limb pain according to HAS criteria for spinal cord stimulation
- Patients able to give informed consent and have signed an informed consent form
- Affiliated to health insurance
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use appropriate contraception during the clinical trial
You will not qualify if you...
- History of drug or alcohol abuse
- Any medical or psychological condition interfering with study protocol (e.g., cancer with limited life expectancy)
- Difficulty with follow-up
- Pregnant or breastfeeding women
- Women of childbearing potential not using contraception
- Adults under legal protection or deprived of liberty
- Within exclusion period for another study
- Participation in another interventional pain study
- Negative 7-day post-implantation test phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
Research Team
S
Sylvie RAOUL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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