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New treatment option for Pain, Intractable
Official title Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
ClinicalTrials.gov ID: NCT05398003
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients aged 18 to 85 years
- Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
- Patients must be able to give informed consent and must have signed an informed consent
- Affiliation to the health insurance
- A negative pregnancy test for women of childbearing potential
You likely can't join if
- \- 7-day post-implantation test phase negative
See the full eligibility criteria
- Patients aged 18 to 85 years
- Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
- Patients must be able to give informed consent and must have signed an informed consent
- Affiliation to the health insurance
- A negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial Non-
- Drug or alcohol abuse
- Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)
- Difficulty with follow-up
- Pregnant or breastfeeding women
- Women of childbearing potential who are not using contraception
- Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty
- Exclusion period for another study
- Participation in another treatment study whose primary objective is based on pain.
- \- 7-day post-implantation test phase negative
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.