Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 1:43 PM
Study NCT ID:
NCT02625805
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2015-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of brain electrical signal in Micro volt.', 'timeFrame': '2 weeks', 'description': 'Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to ADHD state as evaluated by participants questionnaires, and computerized test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.', 'detailedDescription': 'The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.\n\nThe status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female, aged 18 -45 years.\n* Able and willing to comply with all study requirements.\n\nDiagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:\n\n* Adult ADHD Self-Report Scale (ASRS)\n* Wender-Utah Rating Scale\n* Positive And Negative Affect Schedule (PANAS)\n\nExclusion Criteria:\n\nDiagnosed with Psychotic or bipolar disorder.\n\n* Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke\n* A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.\n* Cognitive impairment.\n* Hearing disorder and/or known ear drum impairment.'}, 'identificationModule': {'nctId': 'NCT02625805', 'briefTitle': 'Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brainmarc Ltd.'}, 'officialTitle': 'Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG', 'orgStudyIdInfo': {'id': 'CLD5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants diagnosed with ADD/ADHD', 'description': 'EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration', 'interventionNames': ['Device: EEG monitoring (MindWave by NeuroSky)', 'Device: EEG monitoring (EPOC by Emotiv)', 'Drug: Methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy participants', 'description': 'EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration', 'interventionNames': ['Device: EEG monitoring (MindWave by NeuroSky)', 'Device: EEG monitoring (EPOC by Emotiv)', 'Drug: Methylphenidate']}], 'interventions': [{'name': 'EEG monitoring (MindWave by NeuroSky)', 'type': 'DEVICE', 'description': 'EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset.', 'armGroupLabels': ['Healthy participants', 'Participants diagnosed with ADD/ADHD']}, {'name': 'EEG monitoring (EPOC by Emotiv)', 'type': 'DEVICE', 'description': 'EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.', 'armGroupLabels': ['Healthy participants', 'Participants diagnosed with ADD/ADHD']}, {'name': 'Methylphenidate', 'type': 'DRUG', 'description': 'Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.', 'armGroupLabels': ['Healthy participants', 'Participants diagnosed with ADD/ADHD']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}