Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-28 @ 12:43 PM
Study NCT ID:
NCT05612659
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing an EEG Probe for Studying and Modulating Cognitive Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-23', 'releaseDate': '2025-07-05'}, {'resetDate': '2025-08-11', 'releaseDate': '2025-07-24'}], 'estimatedResultsFirstSubmitDate': '2025-07-05'}}, '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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG oscillations', 'timeFrame': 'change from baseline', 'description': 'Theta (4-8 Hz) oscillations in the mid frontal EEG'}], 'secondaryOutcomes': [{'measure': 'Behavior', 'timeFrame': 'during procedure', 'description': 'Response time in a multi source interference task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-stroke Depression']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)', 'detailedDescription': 'The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.\n\nResults from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.\n2. Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke\n\nExclusion Criteria:\n\n1. Current or lifetime bipolar disorder or schizophrenia diagnosis;\n2. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);\n3. significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:\n4. current chronic severe pain conditions;\n5. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);\n6. skin lesions on electrode placement region;\n7. implanted electrical medical devices;\n8. Pregnancy;\n9. suspected IQ\\<80, and 10) any other clinically relevant reason as judged by the clinician.'}, 'identificationModule': {'nctId': 'NCT05612659', 'acronym': 'PSD', 'briefTitle': 'Developing an EEG Probe for Studying and Modulating Cognitive Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression', 'orgStudyIdInfo': {'id': 'EEG_noninvasive_stimulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Electrical stimulation', 'description': 'Subjects will receive transcranial electrical stimulation.', 'interventionNames': ['Procedure: Transcranial Electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Transcutaneous direct current stimulation', 'description': 'Subjects will receive Transcutaneous direct current stimulation', 'interventionNames': ['Procedure: Transcutaneous direct current stimulation']}], 'interventions': [{'name': 'Transcranial Electrical stimulation', 'type': 'PROCEDURE', 'description': 'Noninvasive electrical stimulation of lateral frontal cortex.', 'armGroupLabels': ['Transcranial Electrical stimulation']}, {'name': 'Transcutaneous direct current stimulation', 'type': 'PROCEDURE', 'description': 'Noninvasive electrical stimulation of the T10 spinal column.', 'armGroupLabels': ['Transcutaneous direct current stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ishita Basu', 'investigatorAffiliation': 'University of Cincinnati'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-05', 'type': 'RELEASE'}, {'date': '2025-07-23', 'type': 'RESET'}, {'date': '2025-07-24', 'type': 'RELEASE'}, {'date': '2025-08-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ishita Basu, Associate Professor, University of Cincinnati'}}}}