Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-08 @ 1:07 AM
Study NCT ID:
NCT02869334
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remediation of Auditory Recognition in Schizophrenia With tDCS
Sponsor:
Organization:
Raw JSON
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extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'sedation', 'notes': 'Moderate sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Auditory Tone Matching Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auditory Remediation With Active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nActive Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'OG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct 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current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Penn Emotion Recognition Test-40 Faces Version', 'unitOfMeasure': 'percent correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Awareness of Social Inference Test (TASIT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auditory Remediation With Active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nActive Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'OG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Auditory Mismatch Negativity (MMN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auditory Remediation With Active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nActive Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'OG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '0', 'groupId': 'OG000'}, {'value': '-.98', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)', 'unitOfMeasure': 'microvolt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed post-testing and had usable data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Auditory Remediation With Active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nActive Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'FG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Auditory Remediation With Active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nActive Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'BG001', 'title': 'Auditory Remediation With Sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week\n\nSham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS\n\nAuditory Remediation: Computer program designed to improve discrimination between sounds'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '44.7', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '42.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tone matching (i.e. ability to match tones following brief delay)', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent correct', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-27', 'size': 504418, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-11T22:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2016-07-19', 'resultsFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-16', 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auditory Tone Matching Task', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Ability to match tones following brief delay'}], 'secondaryOutcomes': [{'measure': 'Auditory Emotion Recognition (AER) Task', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Ability to detect emotion based on tone of voice'}, {'measure': 'ER-40', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Penn Emotion Recognition Test-40 Faces Version'}, {'measure': 'The Awareness of Social Inference Test (TASIT)', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.'}, {'measure': 'Auditory Mismatch Negativity (MMN)', 'timeFrame': 'Change in performance from Baseline at completion of training (week 16)', 'description': 'Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '33539561', 'type': 'DERIVED', 'citation': 'Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.'}], 'seeAlsoLinks': [{'url': 'http://nyspi.org/', 'label': 'New York State Psychiatric Institute'}, {'url': 'http://columbiapsychiatry.org/', 'label': 'Department of Psychiatry, Columbia University Medical Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.', 'detailedDescription': "This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-55\n* Primary diagnosis of Schizophrenia or schizoaffective disorder\n* English fluency\n* Willing/capable to provide informed consent\n* Auditory tone matching deficits\n* Receiving stable doses of antipsychotic medication(s) for at least 2 weeks\n* IQ\\>75\n\nExclusion Criteria:\n\n* Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.\n* Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)\n* Pregnancy or breastfeeding\n* Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)'}, 'identificationModule': {'nctId': 'NCT02869334', 'briefTitle': 'Remediation of Auditory Recognition in Schizophrenia With tDCS', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)', 'orgStudyIdInfo': {'id': '7266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auditory remediation with active tDCS', 'description': 'Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week', 'interventionNames': ['Device: Active Transcranial direct current stimulation (tDCS)', 'Behavioral: Auditory Remediation']}, {'type': 'EXPERIMENTAL', 'label': 'Auditory remediation with sham tDCS', 'description': 'Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week', 'interventionNames': ['Device: Sham Transcranial direct current stimulation (tDCS)', 'Behavioral: Auditory Remediation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control (computer games with sham tDCS)', 'description': 'Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week', 'interventionNames': ['Device: Sham Transcranial direct current stimulation (tDCS)', 'Behavioral: Control computer activities']}], 'interventions': [{'name': 'Active Transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'Active tDCS, where an extremely weak electric current passes through the brain', 'armGroupLabels': ['Auditory remediation with active tDCS']}, {'name': 'Sham Transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'Sham (inactive or placebo) tDCS', 'armGroupLabels': ['Auditory remediation with sham tDCS', 'Control (computer games with sham tDCS)']}, {'name': 'Auditory Remediation', 'type': 'BEHAVIORAL', 'description': 'Computer program designed to improve discrimination between sounds', 'armGroupLabels': ['Auditory remediation with active tDCS', 'Auditory remediation with sham tDCS']}, {'name': 'Control computer activities', 'type': 'BEHAVIORAL', 'description': 'Computer program (e.g. games), which are not designed to improve discrimination between sounds', 'armGroupLabels': ['Control (computer games with sham tDCS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniel Javitt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NY State Psychiatric Institute, Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniel C. Javitt', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}