Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT04439656
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detecting Absence Seizures Using Eye Tracking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004832', 'term': 'Epilepsy, Absence'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084542', 'term': 'Eye-Tracking Technology'}], 'ancestors': [{'id': 'D053483', 'term': 'Eye Movement Measurements'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eysz algorithm to detect absence seizures', 'timeFrame': '1 hour', 'description': 'EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify \\> 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['eye movements', 'seizure detection'], 'conditions': ['Epilepsy, Generalized', 'Absence Epilepsy', 'Absence Seizures', 'Seizures', 'Seizure Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.', 'detailedDescription': 'Seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. People participating in this study will have a routine EEG performed while an eye tracker measures eye movements. After the EEG is complete the researchers will compare the eye movements to the EEG to develop a software program that can detect seizures from eye movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children or adults with absence seizures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form- per local IRB\n2. Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study\n3. Male or female, aged 4-100\n4. Experience known typical absence seizures as defined by the ILAE 2017 classification or referred to EEG lab for staring spell or concern for absence seizure\n\n a. This will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive\n5. Scheduled for clinical EEG observation\n\nExclusion Criteria:\n\n1. Intolerant of wearing or unable to wear the eyeglasses\n2. Autism or other developmental disorder that the PI thinks will interfere with data collection\n3. History of aggression that the PI thinks will interfere with data collection\n4. History of not tolerating EEG that the PI thinks will interfere with data collection\n5. Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent'}, 'identificationModule': {'nctId': 'NCT04439656', 'briefTitle': 'Detecting Absence Seizures Using Eye Tracking', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eysz, Inc.'}, 'officialTitle': 'Detecting Absence Seizures Using Eye Tracking', 'orgStudyIdInfo': {'id': 'DASEY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Absence Seizures', 'description': 'Participants with absence seizures will have their eye movements compared to the EEG recording.', 'interventionNames': ['Diagnostic Test: Eye movement analysis']}], 'interventions': [{'name': 'Eye movement analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Eye movements will be analyzed to identify if seizures are present and compared to the EEG read', 'armGroupLabels': ['Absence Seizures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital, San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Child Neurology', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Rachel Kuperman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eysz, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rachel Kuperman', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital of Orange County", 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research', 'investigatorFullName': 'Rachel Kuperman', 'investigatorAffiliation': 'Eysz, Inc.'}}}}