Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-04 @ 1:13 PM
Study NCT ID:
NCT05443659
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2022-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real-world Data Analysis of REN Treatment in Adolescence 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. \\- this is not a controlled study. it has a single arm, of Nerivio users\n2. \\- Efficacy and medication data were voluntarily provided by patients through the app, which contributed to the fact that not all adolescent users provided the required information at the beginning of the treatment and following two hours.'}}, 'adverseEventsModule': {'timeFrame': 'up to 18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating theitr migraine', 'otherNumAtRisk': 1629, 'deathsNumAtRisk': 1629, 'otherNumAffected': 3, 'seriousNumAtRisk': 1629, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1629, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1629, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Consistent Pain Relief at 2 Hours Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating their migraine and had reported the treatment questionnaire (both T=0h and T=2h) at least twice'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'REN users at the age of 12-=18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and repoerted baseline headache of moderate or severe in T=0h'}, {'type': 'SECONDARY', 'title': 'Consistent Pain Freedom at 2 Hours Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating their migraine and had reported the treatment questionnaire (both T=0h and T=2h) at least twice'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting freedom from pain at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain freedom is defined as reduction from severe or moderate or mild pain to no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and reported a type of headache in T=0h and no headache in the T=2h questionnaire'}, {'type': 'SECONDARY', 'title': 'Consistent Usage of Migraine Abortive (Rescue) Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'OG000'}]}, {'units': 'Treatments with reportad medication', 'counts': [{'value': '2365', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Treatments Performed by Users Aged 12-18', 'description': 'the number of nerivio treatments performed by adolecents with migraine who used the nerivio REN device for treating their migraine'}], 'classes': [{'title': 'Treatments with Nerivio only', 'categories': [{'measurements': [{'value': '1524', 'groupId': 'OG000'}]}]}, {'title': 'Treatments with Nerivio and OTC medications', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}]}]}, {'title': 'reatments with Nerivio andTriptan Rx', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'reatments with Nerivio and other Rx', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects with REN treatments without the use of pharmacological migraine abortive (rescue) medication (either over the counter or prescribed), or with a combination of rescue medication or without any treatment at all at 2 hours post-treatment in at least 50% of all their treatments.', 'unitOfMeasure': 'Treatments with reportad medication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatments with reportad medication', 'denomUnitsSelected': 'Treatments with reportad medication', 'populationDescription': 'REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) or with a combination of Nerivio and rescue medication or without any treatment at all and had at least two evaluable treatments (with data at T=0h and T=2h)'}, {'type': 'SECONDARY', 'title': 'Consistent Functional Disability Relief at 2 Hours Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating their migraine'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting Functional Disability (FD) relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD relief is defined as an improvement from severe or moderate limitation to some or no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and reported a reduction of at least one grade in the functional disability scale at T=2h'}, {'type': 'SECONDARY', 'title': 'Consistent Functional Disability Disappearance at 2 Hours Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating theitr migraine'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting no Functional Disability (FD) at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD disappearance is defined as an improvement from severe or moderate or limitation to no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and had a score of at least 1 in the functional disability scale and reported no functional disability at T=2h'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Intensity Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'OG000'}]}, {'units': 'Nerivio treatments', 'counts': [{'value': '13681', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating theitr migraine'}], 'classes': [{'title': 'Intensity level 1-5', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 6-10', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 11-15', 'categories': [{'measurements': [{'value': '1678', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 16-20', 'categories': [{'measurements': [{'value': '2274', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 21-25', 'categories': [{'measurements': [{'value': '2492', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 26-30', 'categories': [{'measurements': [{'value': '2203', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 31-35', 'categories': [{'measurements': [{'value': '1661', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 36-40', 'categories': [{'measurements': [{'value': '1033', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 41-45', 'categories': [{'measurements': [{'value': '687', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 46-50', 'categories': [{'measurements': [{'value': '529', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 51-55', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 56-60', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 61-65', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 66-70', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 71-75', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 76-80', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 81-85', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 86-90', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Intensity level 91-95', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'tensity level 96-100', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '45 minutes post treatment, up to 16 months from the 1st treatment', 'description': 'The mean intensity of the stimulation collected for all treatments that were performed within the study', 'unitOfMeasure': 'Nerivio treatments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Nerivio treatments', 'denomUnitsSelected': 'Nerivio treatments', 'populationDescription': 'Nerivio users at the age of 12-18 who treated at least once with the Nerivio device'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating theitr migraine'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 months', 'description': 'Incidence of device-related adverse events reported by subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Nerivio users at the age of 12-18 who used the device at least once'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used theNerivio REN device for treating theitr migraine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1629'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1629'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nerivio Users Age 12-18', 'description': 'Adolecents with migraine who used the nerivio REN device for treating theitr migraine'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.9', 'spread': '1.3', 'groupId': 'BG000'}]}]}, {'title': 'Age, female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '1.1', 'groupId': 'BG000'}]}]}, {'title': 'Age, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '1.7', 'groupId': 'BG000'}]}]}, {'title': 'Age, not identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.1', 'spread': '1.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age of participant at the day of creating a nerivio account', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The age was calculated once per all study participants following by a subanalysis for each gender'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1629', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1313', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '258', 'groupId': 'BG000'}]}, {'title': 'Not identifies', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The gender of the participants (female, male, not identified)', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Adolescents with migraine who used the Nerivio REN device for treatment of their migraine'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-01', 'size': 486240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-17T19:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2022-06-25', 'resultsFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-09', 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Intensity Distribution', 'timeFrame': '45 minutes post treatment, up to 16 months from the 1st treatment', 'description': 'The mean intensity of the stimulation collected for all treatments that were performed within the study'}, {'measure': 'Device Related Adverse Events', 'timeFrame': 'Up to 16 months', 'description': 'Incidence of device-related adverse events reported by subjects'}], 'primaryOutcomes': [{'measure': 'Consistent Pain Relief at 2 Hours Post-treatment', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)'}], 'secondaryOutcomes': [{'measure': 'Consistent Pain Freedom at 2 Hours Post-treatment', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting freedom from pain at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain freedom is defined as reduction from severe or moderate or mild pain to no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)'}, {'measure': 'Consistent Usage of Migraine Abortive (Rescue) Medications', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects with REN treatments without the use of pharmacological migraine abortive (rescue) medication (either over the counter or prescribed), or with a combination of rescue medication or without any treatment at all at 2 hours post-treatment in at least 50% of all their treatments.'}, {'measure': 'Consistent Functional Disability Relief at 2 Hours Post-treatment', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting Functional Disability (FD) relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD relief is defined as an improvement from severe or moderate limitation to some or no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation)'}, {'measure': 'Consistent Functional Disability Disappearance at 2 Hours Post-treatment', 'timeFrame': '2 hours post treatment, up to 16 months from the 1st treatment', 'description': 'The proportion of subjects reporting no Functional Disability (FD) at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD disappearance is defined as an improvement from severe or moderate or limitation to no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['migraine, Headache Nerivio, REN'], 'conditions': ['Migraine in Adolescence']}, 'referencesModule': {'references': [{'pmid': '31074005', 'type': 'BACKGROUND', 'citation': 'Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 Sep;59(8):1240-1252. doi: 10.1111/head.13551. Epub 2019 May 9.'}, {'pmid': '34138449', 'type': 'BACKGROUND', 'citation': 'Nierenburg H, Rabany L, Lin T, Sharon R, Harris D, Ironi A, Wright P, Chuang L. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.'}, {'pmid': '34667919', 'type': 'BACKGROUND', 'citation': "Grosberg B, Rabany L, Lin T, Harris D, Vizel M, Ironi A, O'Carroll CP, Schim J. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021 Oct 14;6(4):e966. doi: 10.1097/PR9.0000000000000966. eCollection 2021 Nov-Dec."}, {'pmid': '33349920', 'type': 'BACKGROUND', 'citation': 'Hershey AD, Lin T, Gruper Y, Harris D, Ironi A, Berk T, Szperka CL, Berenson F. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.'}, {'pmid': '32935848', 'type': 'BACKGROUND', 'citation': 'Tepper SJ, Lin T, Montal T, Ironi A, Dougherty C. Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine. Pain Med. 2020 Dec 25;21(12):3522-3529. doi: 10.1093/pm/pnaa299.'}, {'pmid': '36931109', 'type': 'BACKGROUND', 'citation': 'Esparham A, Stark-Inbar A, Jekel L, Tamir S, Rabany L, Ironi A, Gautreaux J, Rao R. Acute Treatment of Migraine in Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN). Pediatr Neurol. 2023 May;142:51-55. doi: 10.1016/j.pediatrneurol.2023.02.008. Epub 2023 Feb 21.'}, {'pmid': '35295483', 'type': 'RESULT', 'citation': 'Ailani J, Rabany L, Tamir S, Ironi A, Starling A. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front Pain Res (Lausanne). 2022 Jan 18;2:753736. doi: 10.3389/fpain.2021.753736. eCollection 2021.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36931109/', 'label': 'Results for NCT05443659'}]}, 'descriptionModule': {'briefSummary': 'This is a Post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, Israel) in adolescents with migraine. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.', 'detailedDescription': "The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute treatment of migraine in patients of 12 years old and above (1-4). It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device\n\nAs part of the sign-up process to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done of their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secured, personal migraine diary, which enables patients to record and track their migraines and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (No limitation, Some limitation, Moderate limitation, Severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.\n\nPost-marketing surveillance is designed to assess the efficacy and safety in larger and more diverse populations and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.\n\nRecently, Real World Evidence (RWE) papers of Nerivio usage in adults were published (5-6). these papers demonstrated the safety and efficacy of the Nerivio device in a large-scale population using the accumulated data gathered by diary within the Nerivio app.\n\nThis post-marketing RWE study investigates the efficacy of the Nerivio treatment using the following outcomes:\n\n1. \\- Reduction in headache pain 2h post-treatment\n2. \\- Improve in functional disability\n3. \\- A standalone treatment vs combination with other therapies\n4. \\- Safety profile (in terms of device-related adverse events)\n\nTogether, these four objectives provide a comprehensive evaluation of efficacy, drug-device interactions, dose stability, and safety, in a large real-world dataset of over XXXXX treatments in the migraine adolescent population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescence (age 12-18) who suffers from migraine who are using the Nerivio device for acute treatment of migraine', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- Age between 12-18 years\n2. \\- REN user across the United States who created Nerivio account on January 1st, 2021 or later.\n3. \\- Had at least two evaluable treatments with the Nerivio device\n\nExclusion Criteria:\n\n(1) - Treatments shorter than 20 minutes'}, 'identificationModule': {'nctId': 'NCT05443659', 'briefTitle': 'Real-world Data Analysis of REN Treatment in Adolescence With Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theranica'}, 'officialTitle': 'Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine in Adolescence', 'orgStudyIdInfo': {'id': 'RWE003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nerivio', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Theranica USA Inc', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'zip': '4250438', 'city': 'Netanya', 'country': 'Israel', 'facility': 'Theranica Bio-Electronics Ltd', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'overallOfficials': [{'name': 'Alit Stark Inbar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Theranica Bio-Electronics ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theranica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}