Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-20 @ 2:33 AM
Study NCT ID:
NCT01968512
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2013-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder
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': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Go/No Go test', 'timeFrame': 'During the only day of the assessment, we will do it before and after tDCS', 'description': 'Neuropsychological test to assess the adequacy of inhibitory control. During the only day of the assessment, we will do it before (after 5 minutes of EEG recording, we will start the Go/No go test keeping the EEG recording for 3 minutes, and after it we will do tDCS) and after the tDCS (after 5 minutes of EEG recording, we will restart the Go/No go test keeping the EEG recording for 3 minutes).'}], 'primaryOutcomes': [{'measure': 'Quantitative electroencephalography', 'timeFrame': 'During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS', 'description': 'Quantitative electroencephalography to assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs.'}], 'secondaryOutcomes': [{'measure': 'Functional Brain Network', 'timeFrame': 'During the only day of the assessment, we will do it before and after tDCS', 'description': 'Functional Brain Network based on the quantitative EEG data through computational and mathematical modeling. During the only day of the assessment, we will do it before (we will get this information from EEG recording during 8 minutes before do the stimulation) and after tDCS(we will get this information from EEG recording during 8 minutes after the stimulation).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder (ADHD);', 'Transcranial Direct Current Stimulation (tDCS);', 'Control Inhibitory;', 'Quantitative electroencephalography;', 'Functional Brain Network;', 'Go/No Go test.'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '26300790', 'type': 'DERIVED', 'citation': 'Cosmo C, Ferreira C, Miranda JG, do Rosario RS, Baptista AF, Montoya P, de Sena EP. Spreading Effect of tDCS in Individuals with Attention-Deficit/Hyperactivity Disorder as Shown by Functional Cortical Networks: A Randomized, Double-Blind, Sham-Controlled Trial. Front Psychiatry. 2015 Aug 4;6:111. doi: 10.3389/fpsyt.2015.00111. eCollection 2015.'}, {'pmid': '26267861', 'type': 'DERIVED', 'citation': 'Cosmo C, Baptista AF, de Araujo AN, do Rosario RS, Miranda JG, Montoya P, de Sena EP. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder. PLoS One. 2015 Aug 12;10(8):e0135371. doi: 10.1371/journal.pone.0135371. eCollection 2015.'}, {'pmid': '25986784', 'type': 'DERIVED', 'citation': 'Cosmo C, Baptista AF, de Sena EP. Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial. JMIR Res Protoc. 2015 May 18;4(2):e56. doi: 10.2196/resprot.4138.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control.', 'detailedDescription': '1. Assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs in patients with ADHD, using quantitative electroencephalography;\n2. Study the contribution of transcranial direct current stimulation compared with sham in the adequacy of inhibitory control in ADHD patients through neuropsychological test-Go/No Go;\n3. Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative EEG in patients with ADHD;\n4. Perform the Reconstruction of the Functional Brain Network of each subject based on the quantitative EEG data through computational and mathematical modeling;\n5. Register indicators of quality of life in adults with Attention Deficit Hyperactivity Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature of the informed consent;\n* Diagnosis of Attention Deficit Hyperactivity Disorder based on DSM-IV-TR and Adult Self-Report Scale (ASRS-18);\n* Adequate eyesight and hearing (or usual corrective methods such as glasses or hearing aid) that allows performing neuropsychological test and questionnaires;\n* Residents in Bahia/Brazil;\n* Over 18 years.\n\nExclusion Criteria:\n\n* Major psychiatric disorders such as schizophrenia and bipolar disorder;\n* Inability to understand the questionnaires used or illiterate;\n* Abuse of psychoactive substances, except nicotine and caffeine, in the last 12 months.'}, 'identificationModule': {'nctId': 'NCT01968512', 'acronym': 'NAADHD', 'briefTitle': 'Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': 'Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.', 'orgStudyIdInfo': {'id': '285.841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Direct Current Stimulation', 'description': 'Subjects will undergo to Transcranial Direct Current Stimulation with anode in left dorsolateral prefrontal cortex and cathode in right supra orbicular region. The stimulus will be 1mA for 20 minutes.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'TDCS-Sham', 'description': 'Subjects will undergo to procedure similar to the Transcranial Direct Current Stimulation with anode in dorsolateral prefrontal cortex and left cathode region supraorbicular right. They will receive a stimulus of 1mA only in initial 30 seconds and it will change the electrical charge for 0mA after this time, however the electrodes will be kept for 20 minutes as the active arm.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'This technique consists in the use of low voltage electric current to increase or reduce neuronal excitability in the area stimulated. This is a non-invasive and safe intervention having infrequent and insignificant side effects characterized by mild local discomfort, itching, tingling and/or headache of short term.', 'armGroupLabels': ['Transcranial Direct Current Stimulation']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Same character of Transcranial Direct Current Stimulation but without current', 'armGroupLabels': ['TDCS-Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40000-000', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Eduardo P de Sena, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Bahia'}, {'name': 'Camila S Cosmo, PhD student', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Eduardo Pondé de Sena', 'investigatorAffiliation': 'Federal University of Bahia'}}}}