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Recruiting

NCT Number: NCT05398003

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

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

Recruiting

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Key information

Conditions

Pain, Intractable Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Location status: Recruiting

Location contact

Sylvie Raoul, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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")

Primary outcomes

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

    Time frame: 6 Months

    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

  2. Evaluating the overall satisfaction with the stimulation mode

    Time frame: 6 Months

    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

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

    Time frame: 6 Months

    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 outcomes

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

    Time frame: 6 Months

    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.

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

    Time frame: 6 Months

    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.

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

    Time frame: 6 Months

    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

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

    Time frame: 6 Months

    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.

  5. 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

    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. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. Comparison of the number of recharges of the device according to the stimulation modes

    Time frame: 6 Months

    Number of recharges of the remote control during the 7 days of stimulation.

  11. Evaluating the change in the quality of life of patients at 1 month

    Time frame: 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)

  12. Evaluating the change in the quality of life of patients at 1 month

    Time frame: 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)

  13. Evaluating the change in the quality of life of patients at 3 months

    Time frame: 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)

  14. Evaluating the change in the quality of life of patients at 3 months

    Time frame: 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)

  15. Evaluating the change in the quality of life of patients at 6 months

    Time frame: 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)

  16. Evaluating the change in the quality of life of patients at 6 months

    Time frame: 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)

  17. Evaluating average daily analgesic consumption at inclusion.

    Time frame: 0 month

    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) .

  18. Evaluating average daily analgesic consumption at 1 month

    Time frame: 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) .

  19. Evaluating average daily analgesic consumption at 3 months

    Time frame: 3 month

    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) .

  20. Evaluating average daily analgesic consumption at 6 months

    Time frame: 6 month

    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) .

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvie RAOUL

CONTACT

[email protected]

02 40 16 50 80

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: S2M

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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