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

NCT05398003 | Recruiting

• 1 other identifier: RC21_0338
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Intractable

Keywords

Medullary stimulation; refractory neck pain

Outcome Measures

Primary Outcomes (3)

• Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.

  Comparison of the average of the visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)score collected during the 7 days of stimulation by the Tonic+Burst mode to the average of the visual analogic scale score collected during the 7 days in tonic stimulation

  6 Months

• Evaluating the overall satisfaction with the stimulation mode

  Daily collection of the patient's evaluation of his satisfaction on the remote control - the patient's logbook by a number of stars: 1\* (one star) not satisfied and 5\* (five stars) very satisfied

  6 Months

• Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.

  Comparison of the average visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome) score of the 7 days of the Tonic+Burst mode compared to the average visual analogic scale scores collected in Tonic stimulation alone.

  6 Months

Secondary Outcomes (20)

• Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode

  6 Months

• Evaluating the non-inferiority of patient satisfaction with their overall comfort

  6 Months

• Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.

  6 Months

• Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency

  6 Months

• Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency

  6 Months

Study Arms (1)

Study population

EXPERIMENTAL

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

Device: Implantation of the WAVEWRITER ALPHA ™ device

Interventions

Implantation of the WAVEWRITER ALPHA ™ device DEVICE

The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities: * tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias * high frequency" stimulation (1000 Hz) "High Frequency". * stimulation in bursts (or "Burst")

Study population

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial
• 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
• Participation in another interventional study whose primary objective is based on pain.

You may not qualify if:

• \- 7-day post-implantation test phase negative

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Pain, Intractable; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sylvie RAOUL

CONTACT

02 40 16 50 80; sylvie.raoul@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will only know the stimulation modes
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hierarchical sequential study with a fixed sequence of 3 successive hypotheses = tested with a 5% risk until one hypothesis is rejected. These three successive hypotheses are a non-inferiority test, followed by two superiority tests.

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 31, 2022
• Study Start: November 23, 2022
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)