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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Intractable
• Intervention / Treatment: Device: Implantation of the WAVEWRITER ALPHA ™ device

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie RAOUL; Phone Number: 02 40 16 50 80; Email: sylvie.raoul@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Sylvie Raoul, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study population; 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; 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")

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Medullary stimulation; refractory neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable
• Other Study ID Numbers: RC21_0338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes