Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-26 @ 12:34 PM
Study NCT ID:
NCT03807934
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Excitability and Cognitive Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-08', 'releaseDate': '2023-03-08'}], 'estimatedResultsFirstSubmitDate': '2023-03-08'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Repeated-measures crossover design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual perceptual performance', 'timeFrame': '36 weeks', 'description': 'Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.'}, {'measure': 'Verbal cognitive performance', 'timeFrame': '36 weeks', 'description': 'Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.'}, {'measure': 'Spatial cognitive performance', 'timeFrame': '72 weeks', 'description': 'Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'cognitive psychology', 'noninvasive brain stimulation', 'electrical brain stimulation'], 'conditions': ['Cognitive Change']}, 'referencesModule': {'references': [{'pmid': '31114491', 'type': 'RESULT', 'citation': 'Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.'}, {'pmid': '30414699', 'type': 'RESULT', 'citation': 'Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.'}, {'pmid': '29375346', 'type': 'RESULT', 'citation': 'Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.'}, {'pmid': '25714417', 'type': 'RESULT', 'citation': 'Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.'}, {'pmid': '25144391', 'type': 'RESULT', 'citation': 'Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Between ages of 18-65.\n\nExclusion Criteria:\n\n* History of adverse reaction to tDCS (trans-cranial direct current stimulation).\n* History of seizure activity.\n* History of head injury (including neurosurgery).\n* History of illness causing brain injury.\n* History of other brain-related condition (such as traumatic brain injury).\n* History of diagnosis with a neurological or psychiatric disorder.\n* History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.\n* History of sensitive scalp.'}, 'identificationModule': {'nctId': 'NCT03807934', 'briefTitle': 'Cerebral Excitability and Cognitive Performance', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Cerebral Excitability and Cognitive Performance', 'orgStudyIdInfo': {'id': '1303018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active High-Definition Stimulation', 'description': 'Active high-definition stimulation of targeted brain regions involved in perception and cognition.', 'interventionNames': ['Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham High-Definition Stimulation', 'description': 'Sham high-definition stimulation of targeted brain regions involved in perception and cognition.', 'interventionNames': ['Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems']}], 'interventions': [{'name': 'Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems', 'type': 'OTHER', 'description': 'Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.', 'armGroupLabels': ['Active High-Definition Stimulation', 'Sham High-Definition Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Tad Brunye', 'investigatorAffiliation': 'Tufts University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-08', 'type': 'RELEASE'}, {'date': '2023-12-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tad Brunye, PI, Tufts University'}}}}