Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04617418
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smartphone Behavior and Epilepsy Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in tapping speed surrounding reported epileptic seizures', 'timeFrame': '3 months', 'description': 'The tapping speed will be measured using the TapCounter app by QuantActions'}, {'measure': 'Changes in number of apps used surrounding reported epileptic seizures', 'timeFrame': '3 months', 'description': 'The number of apps used will be measured using the TapCounter app by QuantActions'}, {'measure': 'Changes in time spent using the smartphone surrounding reported epileptic seizures', 'timeFrame': '3 months', 'description': 'The phone usage in hours will be measured using the TapCounter app by QuantActions'}, {'measure': 'Changes in speed of unlocking the smartphone surrounding reported epileptic seizures', 'timeFrame': '3 months', 'description': 'The unlocking speed will be measured using the TapCounter app by QuantActions'}], 'secondaryOutcomes': [{'measure': 'Recovery after seizure', 'timeFrame': '3 months', 'description': 'See how long does it take to behaviorally recover after a seizure, this will be assessed using the TapCounter app and seeing when phone usage before and after the reported seizure are similar again'}, {'measure': 'Comparison of seizures in diaries and seizures in app use', 'timeFrame': '3 months', 'description': 'See if reported seizure incidence matches with seizure incidence deducted from smartphone measurements'}, {'measure': 'Subgroup analysis', 'timeFrame': '3 months', 'description': 'Analyze differences in behavioural patterns between individuals with different types of epilepsy (e.g. different seizure types or onset zones)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'In this prospective cohort study smartphone behavior surrounding epileptic seizures will be quantified, using a smartphone app, in order to optimize epilepsy evaluation and treatment', 'detailedDescription': 'Rationale:\n\nThe unpredictability of seizures and the unclear behavioral outcomes are major concerns for people with epilepsy and may surface as increased anxiety about independence. This unpredictability is also a true obstacle in capturing and studying seizure-related neurobehavioral alterations themselves. Also, seizures often impact consciousness and thus may go unnoticed. As a result, subjective seizure diaries are unreliable. Continuous smartphone-based monitoring of behavioral output is a fast-emerging topic and proven fruitful in monitoring other neurological disease states. In the field of epilepsy, these tools are yet to be introduced.\n\nObjective:\n\nThe investigators hypothesize that quantifying smartphone behavior will help obtain a detailed and objective behavioral map of seizures that can complement existing subjective seizure diaries and thereby improve the way epilepsy treatments are evaluated in daily practice.\n\nStudy design:\n\nA multicentre observational prospective cohort study with at least 3 months follow-up.\n\nStudy population:\n\n100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.\n\nMain study parameters/endpoints:\n\nChange in touchscreen interactions (tapping speed, texting speed, apps used, location, sleep-wake cycles) surrounding reported epileptic seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* clinical diagnosis of refractory focal epilepsy meeting ILAE criteria16, 17\n* supported by at least one of the following; (1) interictal EEG with epileptiform discharges, (2) epileptogenic lesion on MRI corresponding to the presumed seizure onset zone, or (3) seizure recorded during a video-EEG\n* have a seizure frequency of ≥ 1 per month\n* only one seizure type, or in case of multiple seizure types only seizures that correspond to one probable onset zone (e.g. focal and focal to bilateral tonic-clonic seizures)\n* have daytime seizures (exclusively or both daytime and night-time seizures)\n* mentally competent and with no learning disabilities\n* able to keep a seizure diary including time and date (as judged by the treating physician)\n* have an Android-operating smartphone\n* use their phone with at least 5 distinct smartphone apps at a minimum of 5 days a week\n\nExclusion Criteria:\n\n* not fulfilling the above mentioned inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04617418', 'briefTitle': 'Smartphone Behavior and Epilepsy Management', 'organization': {'class': 'OTHER', 'fullName': 'Stichting Epilepsie Instellingen Nederland'}, 'officialTitle': 'Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management', 'orgStudyIdInfo': {'id': 'SB&EM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with refractory focal epilepsy with a seizure frequency', 'description': 'The investigators will include 100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month, and ask them to keep a seizure diary and use the TapCounter app for three months.', 'interventionNames': ['Behavioral: Change in touchscreen interactions']}], 'interventions': [{'name': 'Change in touchscreen interactions', 'type': 'BEHAVIORAL', 'description': 'The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions', 'armGroupLabels': ['subjects with refractory focal epilepsy with a seizure frequency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5591 VE', 'city': 'Heeze', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Richard Lazeron, MD PhD', 'role': 'CONTACT', 'email': 'LazeronR@Kempenhaeghe.nl'}, {'name': 'Richard Lazeron, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kempenhaeghe', 'geoPoint': {'lat': 51.3828, 'lon': 5.57145}}, {'zip': '2103 SW', 'city': 'Heemstede', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Arthur R van Nieuw Amerongen', 'role': 'CONTACT', 'email': 'avnieuwamerongen@sein.nl', 'phone': '+31235588018'}, {'name': 'Roland D Thijs, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stichting Epilepsie Instellingen Nederland', 'geoPoint': {'lat': 52.34992, 'lon': 4.62301}}, {'zip': '3079 DZ', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Barbara Kuijper, MD PhD', 'role': 'CONTACT', 'email': 'KuijperB@maasstadziekenhuis.nl'}, {'name': 'Evert Kaal, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maasstad ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frans SS Leijten, MD, PhD', 'role': 'CONTACT', 'email': 'policvz@umcutrecht.nl', 'phone': '+31 88 75 579 89'}], 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Arthur R van Nieuw Amerongen', 'role': 'CONTACT', 'email': 'avnieuwamerongen@sein.nl', 'phone': '+31235588018'}], 'overallOfficials': [{'name': 'Roland D Thijs, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stichting Epilepsie Instellingen Nederland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stichting Epilepsie Instellingen Nederland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leiden University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}