Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-05 @ 9:28 PM
Study NCT ID:
NCT05700318
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2023-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Using the ShiraTronics Migraine Therapy System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058542', 'term': 'Implantable Neurostimulators'}], 'ancestors': [{'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monthly Headache Days', 'timeFrame': '12-weeks', 'description': 'Change in number of mean monthly headache days'}], 'secondaryOutcomes': [{'measure': '50% reduction in mean Headache days', 'timeFrame': '12-weeks', 'description': 'Proportion of subjects with 50% reduction in mean monthly headache days'}, {'measure': 'Monthly Migraine Days', 'timeFrame': '12-weeks', 'description': 'Change in mean monthly migraine days'}, {'measure': 'Migraine Disability Assessment Test', 'timeFrame': '12-weeks', 'description': 'Change in disability score'}, {'measure': 'Patient-identified Most Bothersome Symptom', 'timeFrame': '12-weeks', 'description': 'Change in most bothersome symptom'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Migraine, Headache']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who are 22 years of age or older.\n2. History of migraine ≥ 12 months.\n3. Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.\n4. Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.\n5. Stable use of migraine medication.\n\nExclusion Criteria:\n\n1. Post-traumatic headache.\n2. Medication overuse headache.\n3. New daily persistent headache.\n4. Report experiencing unremitting, continuous headaches with no relief.\n5. Previously implanted neurostimulator to treat headache.\n6. History of cervical radiofrequency ablation or had any other intervention/device for migraine.'}, 'identificationModule': {'nctId': 'NCT05700318', 'acronym': 'RELIEV-CM', 'briefTitle': 'Study Using the ShiraTronics Migraine Therapy System', 'organization': {'class': 'INDUSTRY', 'fullName': 'ShiraTronics'}, 'officialTitle': 'A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine', 'orgStudyIdInfo': {'id': 'STCM01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurostimulation', 'description': 'Neurostimulation will be delivered to target nerves.', 'interventionNames': ['Device: neurostimulator']}], 'interventions': [{'name': 'neurostimulator', 'type': 'DEVICE', 'description': 'The ShiraTronics Migraine Therapy System', 'armGroupLabels': ['Neurostimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Broadmeadow', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '+61 2 4985 1860'}], 'facility': 'Genesis Research Services', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'city': 'Hurstville', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '+61 (02) 9570 5550'}], 'facility': 'Australian Medical Research', 'geoPoint': {'lat': -33.9677, 'lon': 151.10149}}, {'city': 'Wayville', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '+61 410 567 855'}], 'facility': 'CerCare', 'geoPoint': {'lat': -34.94468, 'lon': 138.59132}}, {'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '+61 8 9284 6005'}], 'facility': 'Paincare Perth', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'centralContacts': [{'name': 'Fred Ecklund', 'role': 'CONTACT', 'email': 'fecklund@shiratronics.com', 'phone': '1-844-228-7330'}], 'overallOfficials': [{'name': 'Scientific Advisory Board', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ShiraTronics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShiraTronics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}