Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Pain, Intractable

Treatments: Device: Implantation of the WAVEWRITER ALPHA ™ device

Study type: Interventional

Funder types: Other

Identifiers

NCT05398003

RC21_0338

Details and patient eligibility

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Study population

Experimental group

Description:

12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.

Treatment:

Device: Implantation of the WAVEWRITER ALPHA ™ device