Medullary stimulation for treating severe neck pain
Official title: Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Run by Nantes University Hospital · NCT05398003 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Status | Recruiting |
| Started | November 23, 2022 |
| Main results expected | September 23, 2026 |
| Study ends | September 23, 2026 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT05398003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with chronic neck and upper limb pain who can provide informed consent.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific application of medullary stimulation for refractory neck pain is relatively novel.
Who can join: the full rules
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 it's running
-
CHU de Nantes
Nantes, France Recruiting
Study contacts
- Study coordinator: Sylvie RAOUL
- Email: sylvie.raoul@chu-nantes.fr
- Phone: 02 40 16 50 80
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mapping sensations from spinal cord stimulation in people with chronic pain
This project tries to identify the sensations spinal cord stimulation produces and see how those sensations change when stimulation settings are adjusted in adults receiving SCS for chronic pain.
-
Chemogenetic therapy in the anterior cingulate for refractory neuropathic pain
This study will test whether a one-time injection of GA carrying an inhibitory designer receptor into the anterior cingulate, combined with low-dose oral clozapine, can reduce severe neuropathic pain in adults whose pain has not responded to standard treatments.
-
Four-session focal shock wave therapy for vulvodynia in women
This study looks at whether four weekly sessions of low-intensity focal shock wave therapy help women with vulvodynia in real-life clinical practice.
-
Reproducibility of Digital Bite Mark Overlays in Adults
This study tests how consistently different people can create digital bite mark overlays from 3D dental scans in adults who need routine dental care.
-
Dental care for people living with HIV in Pays de la Loire
This study looks at whether people living with HIV in Pays de la Loire need any special dental management based on their health data.
-
68Ga-FAPI-46 PET imaging to stage ATTR-CM and spot progression
This study tests whether a gallium-68 labeled FAPI PET scan can help stage transthyretin cardiac amyloidosis and identify patients whose disease is progressing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.