Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-05 @ 6:29 PM
Study NCT ID:
NCT03398668
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups', 'timeFrame': '1, 2, 24 hours', 'description': 'Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups'}], 'primaryOutcomes': [{'measure': 'Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline', 'timeFrame': '1 hour', 'description': 'visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain'}], 'secondaryOutcomes': [{'measure': 'Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).', 'timeFrame': '2 hours', 'description': 'visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used).'}, {'measure': 'Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).', 'timeFrame': '24 hours', 'description': 'Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).'}, {'measure': 'Proportion of patients not having required rescue medication within 24 hours', 'timeFrame': '24 hours', 'description': 'Proportion of patients not having required rescue medication within 24 hours'}, {'measure': 'Proportion of patients not having required rescue medication at 2 hours compared to baseline.', 'timeFrame': '2 hours', 'description': 'Proportion of patients not having required rescue medication at 2 hours'}, {'measure': 'Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).', 'timeFrame': '1, 2, 24 hours', 'description': 'Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).'}, {'measure': 'Proportion of "responders" ("responder" is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used).', 'timeFrame': '1, 2, 24 hours', 'description': 'visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '35661128', 'type': 'DERIVED', 'citation': 'Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females Ages of 18 to 65 years old.\n2. History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).\n3. Capable to corporate with the study protocol and to sign an informed consent.\n\nExclusion Criteria:\n\n1. Patients having received Botox treatment in the head region in the prior 4 months.\n2. Patients having received supraorbital or occipital nerve blocks in the prior 4 months.\n3. History of Medication Overuse Headache.\n4. Patients using opioid medication.\n5. Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).\n6. Implanted metal or electrical devices in the head (not including dental implants).\n7. Patient having had a previous experience with the Relievion™ device.\n8. Patients who have concomitant epilepsy.\n9. History of neurosurgical interventions.\n10. Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.\n11. History of drug abuse or alcoholism.\n12. Participation in current clinical study or participated in a clinical study within 3 months prior to this study.\n13. Skin lesion or inflammation at the region of the stimulating electrodes.\n14. Personality or somatoform disorder.\n15. Pregnancy or Lactation.\n16. Women with child bearing potential without medically acceptable method of contraception.\n17. History of cerebrovascular event.\n18. Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).\n19. Patients using Cannabis\n20. Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters."}, 'identificationModule': {'nctId': 'NCT03398668', 'briefTitle': 'Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurolief Ltd.'}, 'officialTitle': 'Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine', 'orgStudyIdInfo': {'id': 'SP301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Relievion device- Treatment stimulation', 'description': 'Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation', 'interventionNames': ['Device: Relievion device- Treatment stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator: Relievion device- Sham Stimulation', 'description': 'Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation', 'interventionNames': ['Device: Relievion Device- Sham stimulation']}], 'interventions': [{'name': 'Relievion device- Treatment stimulation', 'type': 'DEVICE', 'otherNames': ['Neurolief device'], 'description': '1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Relievion device- Treatment stimulation']}, {'name': 'Relievion Device- Sham stimulation', 'type': 'DEVICE', 'otherNames': ['Sham Neurolief device'], 'description': '1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Sham Comparator: Relievion device- Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'facility': 'Laniado Medcial Center', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'overallOfficials': [{'name': 'Daniel Dr. Oved, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laniado Medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurolief Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}