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")
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. — 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
Evaluating the overall satisfaction with the stimulation mode — 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
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
