Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
Study NCT ID:
NCT03977350
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The qEEG parameter IS correlation with POCD', 'timeFrame': '1 week following surgery', 'description': 'The qEEG parameter IS, which range between 0 and 1, where higher scores are more favorable than lower scores will be evaluated for its correlation with POCD that will be measured by Montreal Cognitive Assessment (MoCA)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Cognitive complications after major surgery are a common phenomenon. The incidence of Postoperative Cognitive Dysfunction (POCD), may vary from 5% to 25% in adult patients, depending on different risk factors. Age has been strongly associated with cognitive complications. POCD is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. In order to classify evaluate POCD, it requires at least 2 measurements. A baseline, completed before surgery and a second measurement, post surgery.\n\nIn light of the high prevalence of POCD and the difficulties in its prediction, NeuroIndex has developed a quantitative EEG system and software that aim to produces risk predictor index (IS) for POCD. This study aims to evaluate the relationship between the software produced predictor index and the actual POCD events. The qEEG will be monitored during the surgery in addition to the routine clinical practice in operating rooms.\n\nPOCD will be evaluated using Montreal Cognitive Assessment test (MoCA) prior and post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between the ages of 65 or above.\n* Subjects with American Society of Anesthesiologists physical status I-III.\n* Subjects who are intended to undergo cardiac surgery (CABG or valve replacement) under general anesthesia.\n* Surgical procedures scheduled for over 30 minutes.\n* Lack of significant hearing disturbances.\n* Subjects with ability to read and understand the consent form.\n\nExclusion Criteria:\n\n* Significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium.\n* Profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in CAM-ICU).\n* Patients with a history of stroke.\n* Any documented major neurologic or psychiatric dysfunction.\n* Pregnant women.\n* Long term use of sedative-hypnotic drugs and antidepressant drug.\n* Subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).'}, 'identificationModule': {'nctId': 'NCT03977350', 'briefTitle': 'Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuroindex Ltd.'}, 'officialTitle': 'A Blind, Observational, Prospective, Multi -Center, One Arm, Study on the Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)', 'orgStudyIdInfo': {'id': 'CLD5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients over 65 years undergoing heart surgery', 'description': 'Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored', 'interventionNames': ['Device: EEG monitoring']}], 'interventions': [{'name': 'EEG monitoring', 'type': 'DEVICE', 'description': 'EEG monitoring under general anesthesia', 'armGroupLabels': ['Patients over 65 years undergoing heart surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3436212', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Erez Sharoni, Dr', 'role': 'CONTACT', 'email': 'Esharoni@clalit.org.il', 'phone': '972-4-8250621'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ester Pri-Or, Nurse CRA', 'role': 'CONTACT', 'email': 'Ester@neuroindex.com', 'phone': '972-506629699'}, {'name': 'Tamar A Arens, Dr.', 'role': 'CONTACT', 'email': 'Tamar@neuroindex.com', 'phone': '972543532120'}], 'overallOfficials': [{'name': 'Dror Leviner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuroindex Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}