Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-28 @ 1:02 PM
Study NCT ID:
NCT04296604
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in N-Back Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Working Memory Task'}], 'secondaryOutcomes': [{'measure': 'Change in Flanker Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Attention and Inhibitory Control Task'}, {'measure': 'Change in Multi-Source Interference with International Affective Picture System Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Cognitive Control During Emotional Regulation Task'}, {'measure': 'Change in Delayed Discounting Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Decision-Making Task'}, {'measure': 'Change in Stop Signal Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Ability to Inhibit a Response Task'}, {'measure': 'Change in Iowa Gambling Task', 'timeFrame': 'Baseline to Post-Treatment, 1 Week', 'description': 'Risk-Taking Task'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation', 'Executive Function'], 'conditions': ['Traumatic Brain Injury', 'Major Depressive Disorder', 'Bipolar Disorder', 'Schizophrenia', 'Attention Deficit Hyperactivity Disorder', 'Borderline Personality Disorder', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.', 'detailedDescription': 'In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. The investigators will select 8 relevant diagnostic categories: traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorder. The study will also include a cohort of healthy controls for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male and female outpatients 18-65 years of age\n2. A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.\n\nExclusion Criteria\n\n1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.\n2. Active substance dependence (except for tobacco and cannabis).\n3. Pregnant or nursing females.\n4. Inability to participate in testing procedures.\n5. Additional exclusion criteria for healthy controls:\n\n 1. Diagnosis of psychiatric of neurological disorder\n 2. Ongoing treatment with any psychotropic medications.'}, 'identificationModule': {'nctId': 'NCT04296604', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations', 'orgStudyIdInfo': {'id': '2014P001428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traumatic Brain Injury', 'description': 'This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Major Depressive Disorder', 'description': 'This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Bipolar Disorder', 'description': 'This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Schizophrenia', 'description': 'This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Attention Deficit Hyperactivity Disorder', 'description': 'This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Borderline Personality Disorder', 'description': 'This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Substance Use Disorder', 'description': 'This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Controls', 'description': 'This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.', 'armGroupLabels': ['Attention Deficit Hyperactivity Disorder', 'Bipolar Disorder', 'Borderline Personality Disorder', 'Healthy Controls', 'Major Depressive Disorder', 'Schizophrenia', 'Substance Use Disorder', 'Traumatic Brain Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Andreou, BS', 'role': 'CONTACT', 'email': 'bandreou@mgh.harvard.edu', 'phone': '6177248780'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Joan Camprodon, MD, PhD, MPH', 'role': 'CONTACT', 'phone': '6177265348'}, {'name': 'Patricia Cirillo, MD, PhD', 'role': 'CONTACT', 'phone': '6177243217'}], 'overallOfficials': [{'name': 'Joan Camprodon, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation', 'investigatorFullName': 'Joan A Camprodon, MD MPH PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}