Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT05398003
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients will only know the stimulation modes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.', 'timeFrame': '6 Months', 'description': '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'}, {'measure': 'Evaluating the overall satisfaction with the stimulation mode', 'timeFrame': '6 Months', 'description': "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"}, {'measure': 'Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.', 'timeFrame': '6 Months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Evaluating the non-inferiority of patient satisfaction with their overall comfort', 'timeFrame': '6 Months', 'description': "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."}, {'measure': 'Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.', 'timeFrame': '6 Months', 'description': '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'}, {'measure': 'Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency', 'timeFrame': '6 Months', 'description': "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."}, {'measure': 'Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency', 'timeFrame': '6 Months', 'description': "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."}, {'measure': 'Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': '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', 'timeFrame': '6 Months', 'description': '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.'}, {'measure': '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', 'timeFrame': '6 Months', 'description': "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."}, {'measure': 'Comparison of the number of recharges of the device according to the stimulation modes', 'timeFrame': '6 Months', 'description': 'Number of recharges of the remote control during the 7 days of stimulation.'}, {'measure': 'Evaluating the change in the quality of life of patients at 1 month', 'timeFrame': '1 month', 'description': '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)'}, {'measure': 'Evaluating the change in the quality of life of patients at 1 month', 'timeFrame': '1 month', 'description': '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)'}, {'measure': 'Evaluating the change in the quality of life of patients at 3 months', 'timeFrame': '3 months', 'description': '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)'}, {'measure': 'Evaluating the change in the quality of life of patients at 3 months', 'timeFrame': '3 months', 'description': '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)'}, {'measure': 'Evaluating the change in the quality of life of patients at 6 months', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Evaluating the change in the quality of life of patients at 6 months', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'Evaluating average daily analgesic consumption at inclusion.', 'timeFrame': '0 month', 'description': '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) .'}, {'measure': 'Evaluating average daily analgesic consumption at 1 month', 'timeFrame': '1 month', 'description': '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) .'}, {'measure': 'Evaluating average daily analgesic consumption at 3 months', 'timeFrame': '3 month', 'description': '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) .'}, {'measure': 'Evaluating average daily analgesic consumption at 6 months', 'timeFrame': '6 month', 'description': '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) .'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medullary stimulation', 'refractory neck pain'], 'conditions': ['Pain, Intractable']}, 'descriptionModule': {'briefSummary': 'Number of centres planned : 1 (CHU Nantes)\n\nDesign : Randomized, Prospective\n\nPlanning of the study :\n\n* Total duration: 34 months\n* Recruitment period: 24 months.\n* Follow-up time per patients : 7-10 months\n\nExpected number of cases : 12\n\nTreatment, procedure, combination of procedures under consideration :\n\nDuring the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.\n\nThere will be a random draw on the order of the stimulation program:\n\n* 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\n* burst stimulation (or "burst")\n* high frequency" stimulation (1000 Hz) "High frequency: HF".\n* combined tonic + burst stimulation\n* combined tonic + high frequency stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients aged 18 to 85 years\n* Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)\n* Patients must be able to give informed consent and must have signed an informed consent\n* Affiliation to the health insurance\n* A negative pregnancy test for women of childbearing potential\n* Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial\n\nNon-inclusion criteria:\n\n* Drug or alcohol abuse\n* Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)\n* Difficulty with follow-up\n* Pregnant or breastfeeding women\n* Women of childbearing potential who are not using contraception\n* Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty\n* Exclusion period for another study\n* Participation in another interventional study whose primary objective is based on pain.\n\nExclusion criteria:\n\n\\- 7-day post-implantation test phase negative'}, 'identificationModule': {'nctId': 'NCT05398003', 'acronym': 'S2M', 'briefTitle': 'Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain', 'orgStudyIdInfo': {'id': 'RC21_0338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study population', 'description': '12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.', 'interventionNames': ['Device: Implantation of the WAVEWRITER ALPHA ™ device']}], 'interventions': [{'name': 'Implantation of the WAVEWRITER ALPHA ™ device', 'type': 'DEVICE', 'description': '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:\n\n* tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias\n* high frequency" stimulation (1000 Hz) "High Frequency".\n* stimulation in bursts (or "Burst")', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie Raoul, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Sylvie RAOUL', 'role': 'CONTACT', 'email': 'sylvie.raoul@chu-nantes.fr', 'phone': '02 40 16 50 80'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}