An interventional study of Implantation of the WAVEWRITER ALPHA ™ device in Pain, Intractable, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Planning of the study :
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:
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Non-inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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")
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
Time frame: 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
Time frame: 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.
Time frame: 6 Months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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) .
Time frame: 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) .
Time frame: 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) .
Time frame: 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) .
Time frame: 6 month
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Sep 2026, 46 months after the start.
Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's planned 46 months is above that.
How these figures are worked out, and which studies are left out of them.
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