Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-01 @ 10:42 AM
Study NCT ID:
NCT05464069
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2022-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Nerivio in Pregnant Women With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daganh@theranica.com', 'phone': '+972542220121', 'title': 'Dr Dagan Harris, VP Clinical and Regulatory Affairs', 'organization': 'Theranica'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. \\- The retrospective nature of the study may limit the conclusions of this survey by recall bias\n2. \\- The REN group included 59 patients, making it smaller than groups included in other studies assessing the efficacy and safety of migraine treatments in the general population'}}, 'adverseEventsModule': {'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application", 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'spread': '13', 'groupId': 'OG000'}, {'value': '273', 'spread': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significant level \\< 0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The mean number of gestational age at delivery in both study groups (measured in pregnancy days).', 'unitOfMeasure': 'Gestational days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).', 'unitOfMeasure': 'Weight (pounds)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Miscarriage Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of miscarriage in both study groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preterm Birth Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Birth Deficits Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of birth deficits in both study groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Still Births Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of Still birth in both study groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Developmental Milestones Rate Following 3 Months Postnatal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 55 weeks, collected over 2 months', 'description': 'The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Migraine Patterns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'OG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective Data for up to 55 weeks, collected over 2 months', 'description': 'The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'FG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database\n\nNerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application"}, {'id': 'BG001', 'title': 'Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period\n\nMigraine Relief: Any drug for treatment of migraine relief'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '25.8', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The body Mass Index of the participant prior pregnancy', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 513430, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-18T09:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2022-07-12', 'resultsFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-14', 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational Age at Delivery', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The mean number of gestational age at delivery in both study groups (measured in pregnancy days).'}], 'secondaryOutcomes': [{'measure': 'Birth Weight', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).'}, {'measure': 'Miscarriage Rate', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of miscarriage in both study groups'}, {'measure': 'Preterm Birth Rate', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups'}, {'measure': 'Birth Deficits Rate', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of birth deficits in both study groups'}, {'measure': 'Still Births Rate', 'timeFrame': 'Retrospective Data for up to 42 weeks, collected over 2 months', 'description': 'The percent of Still birth in both study groups'}, {'measure': 'Developmental Milestones Rate Following 3 Months Postnatal', 'timeFrame': 'Retrospective Data for up to 55 weeks, collected over 2 months', 'description': 'The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces)'}, {'measure': 'Migraine Patterns', 'timeFrame': 'Retrospective Data for up to 55 weeks, collected over 2 months', 'description': 'The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Migraine', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '37335242', 'type': 'RESULT', 'citation': 'Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970. doi: 10.1111/head.14586. Epub 2023 Jun 19. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37335242/', 'label': 'Pubmed reference'}]}, 'descriptionModule': {'briefSummary': "This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group). Nerivio group participants will be recruited from Theranica's user base. Control group participants will be recruited by health care providers, including headache specialists and OBGYNs (study co-investigators). The study is based on an e-Survey including an e-eligibility questionnaire, an e-ICF ande-Questionnaire. Participants will be compensated for their time.", 'detailedDescription': "This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group).\n\nStudy group: Study group participants will be recruited from Nerivio's user base. An invitation message will be sent via in-app notification and/or email to all Nerivio users who are (1) female, AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st, 2021. Users who meet these criteria will be invited to fill in a screening and eligibility questionnaire. If they meet the eligibility criteria, they will be offered the opportunity to participate in the study. Participants will complete and sign an electronic informed consent form. Following consent, participants will be asked to complete the questionnaire. Once complete, participants will be compensated for their time.\n\nControl group: Control group participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period. Patients interested in participating will be directed to the same screening and eligibility questionnaire and will follow the same study design.\n\nEndpoints focus on the health of the mother and the baby, during pregnancy and three months postpartum.\n\nPrimary endpoint:\n\nDemonstrate that the study group is not different than the control group in regard to gestational age at delivery (measured in pregnancy weeks).\n\nSecondary endpoints:\n\nDemonstrate that the study group is not different from the control group in:\n\n1. Baby's birth weight (average birth weight)\n2. Miscarriage rate (% of miscarriage cases)\n3. Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy weeks less than 37)\n4. Birth deficits rate (% of birth deficits)\n5. Still births rate (% of still births)\n6. Meeting developmental milestones following 3 months postnatal (% of babies)\n7. Visits to the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period (# of events)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."', 'genderDescription': 'Postpartum women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with migraine\n2. History of migraine pre-pregnancy with an average of at least 4 migraine days per month, in the six months prior to the last pregnancy\n3. History of pregnancy with last menstrual period (LMP) between November 1st, 2019 - March 31st, 2021. Pregnancy within this time window is the pregnancy of study, termed "study pregnancy"\n4. Between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy"\n5. History of at least 4 migraine attacks during "study pregnancy"\n6. In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during "study pregnancy"\n7. In the control group: No history of using Nerivio, ever\n\nExclusion Criteria:\n\n1. History of preterm birth (gestational age at deliver\\<37 weeks) in previous pregnancies prior to the "study pregnancy"\n2. History of congenital malformations or birth defects in previous pregnancies prior to the "study pregnancy"\n3. Severe other diseases which started before the "study pregnancy" and lasted into the "study pregnancy" period, including congenital heart disease, arrhythmia, history of myocardial infarction (MI), history of stroke, or active cancer\n4. Serious physical injury that occurred during the "study pregnancy": severe car collision injury, serious injury at home/work, etc. Multiple gestation (i.e., pregnancy with more than one baby at a time, such as pregnancy with twins, triplets, and quadruplets) in the "study pregnancy"'}, 'identificationModule': {'nctId': 'NCT05464069', 'briefTitle': 'Safety of Nerivio in Pregnant Women With Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theranica'}, 'officialTitle': 'A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum', 'orgStudyIdInfo': {'id': 'TCH011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postpartum females with migraine who used Nerivio during their pregnancy', 'description': "Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database", 'interventionNames': ['Device: Nerivio']}, {'label': 'Postpartum females with migraine who used other migraine therapy during their pregnancy', 'description': 'Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period', 'interventionNames': ['Drug: Migraine Relief']}], 'interventions': [{'name': 'Nerivio', 'type': 'DEVICE', 'otherNames': ['Neriivo'], 'description': 'Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application', 'armGroupLabels': ['Postpartum females with migraine who used Nerivio during their pregnancy']}, {'name': 'Migraine Relief', 'type': 'DRUG', 'otherNames': ['migraine treatment'], 'description': 'Any drug for treatment of migraine relief', 'armGroupLabels': ['Postpartum females with migraine who used other migraine therapy during their pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego (UCSD)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Theranica USA', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}], 'overallOfficials': [{'name': 'Alit Stark Inbar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Theranica USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theranica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}