Pain, IntractableS2MNCT05398003
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
A study testing Implantation of the WAVEWRITER ALPHA ™ device in people with Pain, Intractable, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Intractable
- What is being tested?
- Implantation of the WAVEWRITER ALPHA ™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Participation in another interventional study whose primary objective is based on pain.
- 7-day post-implantation test phase negative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Sylvie Raoul, MD
About this study
Official title: Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Read more
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
- Conditions
- Pain, Intractable
- Being tested
- Implantation of the WAVEWRITER ALPHA ™ device
- Keywords
- Medullary stimulation, refractory neck pain
- Medical subject headings
- Pain, Intractable, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the WAVEWRITER ALPHA ™ deviceDevice
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 group | Role | What they receive |
|---|---|---|
| Study population | Experimental | 12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included. Receives: Device: Implantation of the WAVEWRITER ALPHA ™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 6 Months
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start23 Nov 2022
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398003
- Sponsor's protocol ID
- RC21_0338
- Acronym
- S2M
- Status last verified
- Nov 2024
- First submitted
- 20 May 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
- ClinicalTrials.gov ID
- NCT05398003
- Acronym / sponsor ID
- S2M / RC21_0338
- Conditions
- Pain, Intractable
- Keywords
- Medullary stimulation, refractory neck pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Device: Implantation of the WAVEWRITER ALPHA ™ device12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in another interventional study whose primary objective is based on pain.
- 7-day post-implantation test phase negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the WAVEWRITER ALPHA ™ deviceThe 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") | Device | Study population |
Primary outcome
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
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
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.
20 secondary outcomes
Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode
Time frame: 6 Months
Evaluating the non-inferiority of patient satisfaction with their overall comfort
Time frame: 6 Months
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
Time frame: 6 Months
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency
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
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
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
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
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
Time frame: 6 Months
Comparison of the number of recharges of the device according to the stimulation modes
Time frame: 6 Months
Evaluating the change in the quality of life of patients at 1 month
Time frame: 1 month
Evaluating the change in the quality of life of patients at 1 month
Time frame: 1 month
Evaluating the change in the quality of life of patients at 3 months
Time frame: 3 months
Evaluating the change in the quality of life of patients at 3 months
Time frame: 3 months
Evaluating the change in the quality of life of patients at 6 months
Time frame: 6 months
Evaluating the change in the quality of life of patients at 6 months
Time frame: 6 months
Evaluating average daily analgesic consumption at inclusion.
Time frame: 0 month
Evaluating average daily analgesic consumption at 1 month
Time frame: 1 month
Evaluating average daily analgesic consumption at 3 months
Time frame: 3 month
Evaluating average daily analgesic consumption at 6 months
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the WAVEWRITER ALPHA ™ device in people with Pain, Intractable, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie RAOUL (02 40 16 50 80, sylvie.raoul@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.