Actively Recruiting
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Led by Nantes University Hospital · Updated on 2024-11-18
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of multimodal medullary stimulation to manage chronic neck and upper limb pain in patients who have not responded to other treatments. The study is randomized and prospective, aiming to assess different stimulation modes delivered by the WAVEWRITER ALPHA™ system to reduce pain and improve patient satisfaction. Participants will receive an implant of the WAVEWRITER ALPHA™ device, which delivers electrical stimulation to the spinal cord. The study evaluates five stimulation modes: tonic low frequency, burst stimulation, high frequency (1000 Hz), combined tonic plus burst, and combined tonic plus high frequency. The order of these stimulation programs will be randomly assigned to each patient to compare their effects. Throughout the study, which lasts up to 34 months with individual follow-up between 7 to 10 months, patients will be monitored for pain reduction, satisfaction with stimulation, quality of life changes, and analgesic use. Researchers will also assess device recharge frequency and overall comfort with each mode. Safety and adherence will be tracked during scheduled visits and assessments.
CONDITIONS
Brief 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
- 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 trial
You will not qualify if you...
- Drug or alcohol abuse
- Any medical or psychological problem that may interfere with the study, such as 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
- Currently in an exclusion period for another study
- Participation in another interventional pain study
- Negative result during 7-day post-implantation test phase
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 - 1 day
Participants undergo implantation of the WAVEWRITER ALPHA ™ device for medullary stimulation targeting refractory neck and upper limb pain.
1 visit (in-person)
Duration - 6 months
Participants receive medullary stimulation using different stimulation modes including tonic, high frequency, and burst, in a randomized sequence.
Regular visits for device programming and assessments over 6 months
Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
Research Team
S
Sylvie RAOUL
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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