Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
Study NCT ID:
NCT01436695
Status:
UNKNOWN
Last Update Posted:
2011-09-20
First Post:
2011-09-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'lastUpdateSubmitDate': '2011-09-19', 'studyFirstSubmitDate': '2011-09-17', 'studyFirstSubmitQcDate': '2011-09-19', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lack of adverse events', 'timeFrame': '1-2 weeks'}], 'secondaryOutcomes': [{'measure': 'Epicall feasibility for monitoring pre-seizure biomarkers', 'timeFrame': '1-2 weeks', 'description': 'Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['seizure early detection'], 'conditions': ['Seizure']}, 'descriptionModule': {'briefSummary': 'Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.\n\nThe Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:\n\n1. Heart Rate (base line, increase, decrease, asystole).\n2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children age 1 year -18 years old.\n* Hospitalized patient who is diagnosed with epilepsy.\n* Patient's parents/care giver able to comprehend and give informed consent for participation in this study.\n* Patient's parents/care giver must commit to both screening and monitoring visits.\n* Patient's parents/care giver must sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area\n* General weakness.\n* Patient's parents/care giver objects to the study protocol.\n* Concurrent participation in any other clinical study.\n* Physician objection."}, 'identificationModule': {'nctId': 'NCT01436695', 'briefTitle': 'Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epicall LTD'}, 'officialTitle': 'Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers', 'orgStudyIdInfo': {'id': 'EPC - 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epicall group', 'description': 'patients will be connected to Epicall sensor', 'interventionNames': ['Device: Epicall']}], 'interventions': [{'name': 'Epicall', 'type': 'DEVICE', 'description': 'The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.', 'armGroupLabels': ['Epicall group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zrifin', 'country': 'Israel', 'contacts': [{'name': 'Hanna Levy, Dr', 'role': 'CONTACT', 'email': 'hanna@qsitemed.com', 'phone': '+972-4638-8837'}, {'name': 'Eli Heyman, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asaf Harofeh Medical Center'}], 'centralContacts': [{'name': 'Hanna Levy, Dr', 'role': 'CONTACT', 'email': 'hanna@qsitemed.com', 'phone': '+972-4-638-8837'}], 'overallOfficials': [{'name': 'Eli Heyman, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofeh Medical Center, Zrifin Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicall LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}