Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-01 @ 1:48 AM
Study NCT ID:
NCT02344706
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2015-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D013226', 'term': 'Status Epilepticus'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value of EEG', 'timeFrame': '60min', 'description': 'EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Emergency Care, Prehospital', 'Coma', 'Electroencephalography'], 'conditions': ['Epilepsy', 'Status Epilepticus']}, 'descriptionModule': {'briefSummary': 'A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients unconscious due to seizures in the prehospital field', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unconsciousness due to seizures in the prehospital field\n\nExclusion Criteria:\n\n* Cardiac arrest\n* Traumatic unconsciousness'}, 'identificationModule': {'nctId': 'NCT02344706', 'briefTitle': 'Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus', 'orgStudyIdInfo': {'id': '237/3 03.12.2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mini-EEG, NCSE', 'description': 'Unconscious patients due to seizures, of whom EEG is registered', 'interventionNames': ['Device: Registration of EEG']}], 'interventions': [{'name': 'Registration of EEG', 'type': 'DEVICE', 'description': 'EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.', 'armGroupLabels': ['Mini-EEG, NCSE']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Johannes Björkman, MD', 'role': 'CONTACT', 'email': 'johannes.bjorkman@helsinki.fi', 'phone': '094711'}, {'name': 'Tom Silfvast, MD, PhD', 'role': 'CONTACT', 'phone': '094711'}], 'overallOfficials': [{'name': 'Tom Silfvast, MD, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Johannes Björkman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Salmi Tapani, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Johannes Björkman', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}