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

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain

Conditions
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Pain, Intractable

Intervention / Treatment
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* Device: Implantation of the WAVEWRITER ALPHA ™ device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study population<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the non-inferiority of patient pain 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) scores collected during the 7 days of stimulation by the combined Tonic+High Frequency mode to the average of the visual analogic scale scores collected during the 7 days of tonic stimulation. | 6 Months | 
| Evaluating the non-inferiority of patient satisfaction with their overall comfort | Daily collection of the patient's evaluation of his satisfaction on the patient's notebook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. During the 7 days of stimulation by Low frequency + High frequency. | 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 combined mode Tonic+ High Frequency compared to the average visual analogic scale scores collected in Tonic stimulation alone | 6 Months | 
| Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency | Daily collection of the patient's evaluation of his or her satisfaction on the patient logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. | 6 Months | 
| Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency | Daily collection of the patient's evaluation of his or her satisfaction on the patient 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 (low frequency + high frequency) compared to the tonic mode (low frequency) only | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 6 Months | 
| Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 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 | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 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 | Daily collection of the patient's evaluation of his or her satisfaction on the patient logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. | 6 Months | 
| Comparison of the number of recharges of the device according to the stimulation modes | Number of recharges of the remote control during the 7 days of stimulation. | 6 Months | 
| Evaluating the change in the quality of life of patients at 1 month | Comparison of the evolution of quality of life from inclusion to 1 month with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 1 month | 
| Evaluating the change in the quality of life of patients at 1 month | Comparison of the evolution of quality of life from inclusion to 1 month with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 1 month | 
| Evaluating the change in the quality of life of patients at 3 months | Comparison of the evolution of quality of life from inclusion to 3 months with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 3 months | 
| Evaluating the change in the quality of life of patients at 3 months | Comparison of the evolution of quality of life from inclusion to 3 months with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 3 months | 
| Evaluating the change in the quality of life of patients at 6 months | Comparison of the evolution of quality of life from inclusion to 6 months with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 6 months | 
| Evaluating the change in the quality of life of patients at 6 months | Comparison of the evolution of quality of life from inclusion to 6 months with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 6 months | 
| Evaluating average daily analgesic consumption at inclusion. | Collection of the number and type of analgesic treatments per day for one week prior to the inclusion visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 0 month | 
| Evaluating average daily analgesic consumption at 1 month | Collection of the number and type of analgesic treatments per day for one week prior to the month 1 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 1 month | 
| Evaluating average daily analgesic consumption at 3 months | Collection of the number and type of analgesic treatments per day for one week prior to the month 3 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 3 month | 
| Evaluating average daily analgesic consumption at 6 months | Collection of the number and type of analgesic treatments per day for one week prior to the month 6 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medullary stimulation, refractory neck pain