Medullary stimulation for treating severe neck pain
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
This study is testing a new spinal cord stimulation device to see if it can help people with severe neck pain that hasn't responded to other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05398003 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of the WAVEWRITER ALPHA™ system for patients suffering from refractory neck pain. It is a randomized, prospective study conducted at a single center, CHU Nantes, over a total duration of 34 months, with a recruitment period of 24 months. Participants will receive different modes of spinal cord stimulation, including tonic, burst, and high-frequency stimulation, to evaluate their effectiveness in reducing pain. The follow-up period for each patient will last between 7 to 10 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with chronic neck and upper limb pain who can provide informed consent.
Not a fit: Patients with drug or alcohol abuse issues, significant medical or psychological problems, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic neck pain for patients who have not responded to other treatments.
How similar studies have performed: While similar approaches have been explored, this specific application of medullary stimulation for refractory neck pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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-inclusion criteria: * 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 interventional study whose primary objective is based on pain. Exclusion criteria: \- 7-day post-implantation test phase negative
Where this trial is running
Nantes
- CHU de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Sylvie RAOUL
- Email: sylvie.raoul@chu-nantes.fr
- Phone: 02 40 16 50 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.