Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-03 @ 3:06 PM
Study NCT ID:
NCT02523105
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.', 'timeFrame': '12 months', 'description': 'Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fpsyt.2017.00128/full', 'label': 'A Pilot Study of Possible Easy-to-Use Electrophysiological Index for Early Detection of Antidepressive Treatment Non-Response'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.', 'detailedDescription': 'The study will be conducted in two arms:\n\nIn arm I, participants diagnosed with depression. In arm II, healthy participants.\n\nArm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.\n\nArm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 18 -70 years (Adult, Senior)\n* Able and willing to comply with all study requirements.\n\nAdditional Inclusion Criteria for Arm I\n\n* Diagnosed with depression\n* Being within 2 days of receiving pharmaceutical treatment for depression for the first\n\ntime or changing dose or changing type of current pharmaceutical treatment or addition to\n\ndrug of current pharmaceutical treatment.\n\nAdditional Inclusion Criteria for Arm II\n\nBrief Symptom Inventory (BSI \\< 2.3).\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Diagnosed with Psychotic disorder.\n* Diagnosed with Central Neurological disorder.\n* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse\n\nor dependence.\n\n* Hearing disorder and/or known ear drum impairment.\n* High suicide risk as judged by the research team.'}, 'identificationModule': {'nctId': 'NCT02523105', 'briefTitle': 'Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment', 'nctIdAliases': ['NCT02583724'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Brainmarc Ltd.'}, 'officialTitle': 'Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.', 'orgStudyIdInfo': {'id': '0010-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Participants diagnosed with depression.', 'description': 'EEG monitoring and evaluation', 'interventionNames': ['Device: EEG monitoring']}, {'type': 'OTHER', 'label': 'Healthy participants.', 'description': 'EEG monitoring and evaluation', 'interventionNames': ['Device: EEG monitoring']}], 'interventions': [{'name': 'EEG monitoring', 'type': 'DEVICE', 'description': 'EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php).\n\nEEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.', 'armGroupLabels': ['Healthy participants.', 'Participants diagnosed with depression.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18341', 'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Hod HaSharon', 'country': 'Israel', 'facility': 'Shalvata Hospital', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'overallOfficials': [{'name': 'Yuval Bloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shalvata Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brainmarc Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}