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

Primary Purpose

Pain, Intractable

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Implantation of the WAVEWRITER ALPHA ™ device
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Intractable focused on measuring Medullary stimulation, refractory neck pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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)
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) .
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) .
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) .
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) .

Full Information

First Posted
May 20, 2022
Last Updated
December 2, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05398003
Brief Title
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Acronym
S2M
Official Title
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
September 25, 2025 (Anticipated)
Study Completion Date
September 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable
Keywords
Medullary stimulation, refractory neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Masking Description
Patients will only know the stimulation modes
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study population
Arm Type
Experimental
Arm Description
12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.
Intervention Type
Device
Intervention Name(s)
Implantation of the WAVEWRITER ALPHA ™ device
Intervention Description
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 Measure Information:
Title
Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
Description
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
Time Frame
6 Months
Title
Evaluating the overall satisfaction with the stimulation mode
Description
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
Time Frame
6 Months
Title
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode
Description
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.
Time Frame
6 Months
Title
Evaluating the non-inferiority of patient satisfaction with their overall comfort
Description
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.
Time Frame
6 Months
Title
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
Description
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
Time Frame
6 Months
Title
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency
Description
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.
Time Frame
6 Months
Title
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency
Description
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.
Time Frame
6 Months
Title
Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only
Description
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.
Time Frame
6 Months
Title
Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only
Description
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.
Time Frame
6 Months
Title
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
Description
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.
Time Frame
6 Months
Title
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
Description
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.
Time Frame
6 Months
Title
Comparison of the number of recharges of the device according to the stimulation modes
Description
Number of recharges of the remote control during the 7 days of stimulation.
Time Frame
6 Months
Title
Evaluating the change in the quality of life of patients at 1 month
Description
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)
Time Frame
1 month
Title
Evaluating the change in the quality of life of patients at 1 month
Description
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)
Time Frame
1 month
Title
Evaluating the change in the quality of life of patients at 3 months
Description
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)
Time Frame
3 months
Title
Evaluating the change in the quality of life of patients at 3 months
Description
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)
Time Frame
3 months
Title
Evaluating the change in the quality of life of patients at 6 months
Description
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)
Time Frame
6 months
Title
Evaluating the change in the quality of life of patients at 6 months
Description
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)
Time Frame
6 months
Title
Evaluating average daily analgesic consumption at inclusion.
Description
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) .
Time Frame
0 month
Title
Evaluating average daily analgesic consumption at 1 month
Description
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) .
Time Frame
1 month
Title
Evaluating average daily analgesic consumption at 3 months
Description
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) .
Time Frame
3 month
Title
Evaluating average daily analgesic consumption at 6 months
Description
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) .
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie RAOUL
Phone
02 40 16 50 80
Email
sylvie.raoul@chu-nantes.fr
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Raoul, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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