Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of the WAVEWRITER ALPHA ™ device.
- Who it may be relevant to
- Registry conditions: Pain, Intractable. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Overview
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
Interventions
- Device Implantation of the WAVEWRITER ALPHA ™ 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")
Primary outcome measures
- Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. [Time frame: 6 Months]
- Evaluating the overall satisfaction with the stimulation mode [Time frame: 6 Months]
- Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. [Time frame: 6 Months]
Secondary outcome measures (12)
- Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode [Time frame: 6 Months]
- Evaluating the non-inferiority of patient satisfaction with their overall comfort [Time frame: 6 Months]
- Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. [Time frame: 6 Months]
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency [Time frame: 6 Months]
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency [Time frame: 6 Months]
- Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only [Time frame: 6 Months]
- Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only [Time frame: 6 Months]
- Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the pain criteria [Time frame: 6 Months]
- Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the satisfaction [Time frame: 6 Months]
- Comparison of the number of recharges of the device according to the stimulation modes [Time frame: 6 Months]
- Evaluating the change in the quality of life of patients at 1 month [Time frame: 1 month]
- Evaluating the change in the quality of life of patients at 1 month [Time frame: 1 month]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT05398003 · RC21_0338