Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT07227194
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2025-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Machine Learning Assessment of Next-Day Migraine Likelihood
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53065}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-11-09', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Precision of the prediction model', 'timeFrame': '24 hours', 'description': 'The percentage of migraine days correctly predicted, out of all predicted days.'}], 'secondaryOutcomes': [{'measure': 'Specificity of the prediction model', 'timeFrame': '24 hours', 'description': 'The percentage of non-migraine days correctly predicted, out of all the non-migraine days'}, {'measure': 'Sensitivity of the prediction model', 'timeFrame': '24 hours', 'description': 'The percentage of migraine days correctly predicted, out of all the migraine days.'}, {'measure': 'Accuracy of the prediction model', 'timeFrame': '24 hours', 'description': 'The percentage of days correctly predicted (migraine and non-migraine), out of all the predicted days'}, {'measure': 'Area Under the Curve (AUC)', 'timeFrame': '24 hours', 'description': "The probability that the model ranks a migraine day higher than a non-migraine day, based on predicted risk scores (summarizing the model's ability to distinguish between migraine and non-migraine days across all classification thresholds)."}, {'measure': 'F1 score for the prediction model', 'timeFrame': '24 hours', 'description': 'The balance between correctly predicted migraine days and avoiding wrongly-predicted migraine days, combining sensitivity and precision in one measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine treatment', 'Machine learning', 'Nerivio app'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Development of a machine learning (ML) algorithm for assessment of next-day migraine likelihood, drawing on self-reported migraine-related information, and geographic location, collected via the Nerivio app- a mobile application used for migraine treatment by the Remote Electrical Neuromodulation (REN) wearable device.', 'detailedDescription': 'The analysis set includes patients with migraine who used Nerivio app for the reporting of migraine attacks and/or associated symptoms and/or migraine-related information.\n\nData collection is through the Nerivio app (Nerivio®). During app registration, patients consent to the collection of de-identified data for research purposes and provide demographic information. Participants can voluntarily report baseline characteristics such as treatment onset time relative to attack onset, headache pain, functional disability, and presence/absence of migraine-associated symptoms, as well as treatment outcomes 2-hours post-treatment. All data is stored on a HIPAA-compliant secure server.\n\nThe algorithm will be trained on user-level data. The dataset will be structured as a tabular matrix, where the columns represent risk-related features and the rows represent user-day observations. The feature set (X) serves as input variables, while the migraine occurrence label (Y) is the target outcome. The feature set (X) could be divided into four groups, according to the data source:\n\nDemographic data - age and sex were self-reported via the app upon registration. The user\'s country is identified based on IP address.\n\nQuestionnaire data - features which are the patient\'s answers to either the daily diary questionnaire or a pre-treatment questionnaire. These include headache severity, functional disability, medication intake, aura, pain duration, and prodromal symptoms. Data on prodromal symptoms is collected via a multiple-choice question with 14 pre-defined answers.\n\nWeather data - environmental features that are based on users\' geographic location. These include barometric pressure, temperature, heat index, UV index, wind, humidity, and precipitation.\n\nCalculated features - features that are calculated based on the aforementioned collected data. These include averages, frequencies, number of consecutive days, etc\'.\n\nLabel (Y) Definition - The target variable (Y) will be defined using daily diary entries and pre-treatment questionnaires. The "next-day migraine" field served as the target outcome. A value of 1 (migraine day) will be assigned if a migraine was reported on the subsequent calendar day; a value of 0 (non-migraine day) will be assigned if no migraine was reported. Missing values were kept as null to capture potential information inherent in their non-random occurrence.\n\nA day is classified as a migraine day (Y = 1) if both of the following conditions were met: A) Headache level was reported as mild, moderate, or severe in the diary or pre-treatment questionnaire. B) At least one additional migraine indicator was present: intake of migraine-related medication, or report of photophobia, phonophobia, nausea and/or vomiting, or aura in the diary or pre-treatment questionnaire.\n\nThe following standard ML outcome measures were used to evaluate model performance:\n\nPrecision- the percentage of migraine days correctly predicted, out of all predicted days.\n\nAccuracy- the percentage of days correctly predicted (migraine and non-migraine), out of all the predicted days.\n\nSensitivity (also termed recall rate)- the percentage of migraine days correctly predicted, out of all the migraine days.\n\nSpecificity- the percentage of non-migraine days correctly predicted, out of all the non-migraine days.\n\nArea Under the Curve (AUC)- the probability that the model ranks a migraine day higher than a non-migraine day, based on predicted risk scores (summarizing the model\'s ability to distinguish between migraine and non-migraine days across all classification thresholds).\n\nF1 score- the balance between correctly predicted migraine days and avoiding wrongly-predicted migraine days, combining sensitivity and precision in one measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine patients that were prescribed and treated their migraine with the Nerivio device', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- Nerivio users age 8 and above.\n2. \\- Filled at least 2 daily diaries/ pre-treatment reports via the Nerivio app during the same month.\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT07227194', 'briefTitle': 'Machine Learning Assessment of Next-Day Migraine Likelihood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theranica'}, 'officialTitle': 'Machine Learning Assessment Of Next-Day Migraine Likelihood Collected Via The Nerivio App', 'orgStudyIdInfo': {'id': 'RWE-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine patients who used the Nerivio device app', 'description': 'Nerivio users age 8 and above, who had filled at least 2 daily diaries or pre-treatment reports via the Nerivio app during the same month.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Theranica USA Inc', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Liron Rabany, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theranica Bio-Electronics ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theranica', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'WCG IRB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}