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

Pain, Intractable Clinical Trial

— S2M  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398003
• Other study ID #: RC21_0338
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: September 25, 2025

Study information

• Verified date: December 2022
• Source: Nantes University Hospital
• Contact: Sylvie RAOUL
• Phone: 02 40 16 50 80
• Email: sylvie.raoul[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 25, 2025
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Intractable

Intervention

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")

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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