Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-02 @ 3:29 PM
Study NCT ID:
NCT05627661
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Devices to Monitor Seizures in Autoimmune Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015374', 'term': 'Biosensing Techniques'}], 'ancestors': [{'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of high-quality physiological signals', 'timeFrame': '10 days', 'description': 'Total number of high-quality physiological signals recorded by biosensors'}, {'measure': 'Number of Reproducible changes in physiological biosignals', 'timeFrame': '10 days', 'description': 'Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Epilepsy', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with or suspected of having autoimmune epilepsy.\n* Normal controls - cognitively normal subjects without epilepsy\n\nExclusion Criteria:\n\n• Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).'}, 'identificationModule': {'nctId': 'NCT05627661', 'briefTitle': 'Wearable Devices to Monitor Seizures in Autoimmune Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Managing Multiple Seizure Types With Wearable Devices', 'orgStudyIdInfo': {'id': '22-006702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autoimmune Epilepsy with Biosensors', 'description': 'Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.', 'interventionNames': ['Device: Biosensor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Controls with Biosensors', 'description': 'Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.', 'interventionNames': ['Device: Biosensor']}], 'interventions': [{'name': 'Biosensor', 'type': 'DEVICE', 'description': 'Noninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days', 'armGroupLabels': ['Autoimmune Epilepsy with Biosensors', 'Healthy Controls with Biosensors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Benjamin Brinkmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin H. Brinkmann', 'investigatorAffiliation': 'Mayo Clinic'}}}}