Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT03995368
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neuroplasticity in TBI and Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jonathan.Wynn@va.gov', 'phone': '3104783711', 'title': 'Dr. Jonathan K. Wynn', 'phoneExt': '44957', 'organization': 'VA Greater Los Angeles Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations mainly revolved around the study being interrupted and participant flow by the COVID-19 pandemic. However, the investigators largely met recruitment goals and successfully completed the study.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Does not differ. Total number of participants reflect those who met inclusion criteria and completed the study.', 'eventGroups': [{'id': 'EG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.", 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mismatch Negativity (MMN) Amplitudes in Microvolts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'classes': [{'title': 'MMN2', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'MMN6', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '2.11', 'groupId': 'OG002'}]}]}, {'title': 'MMN36', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-2.90', 'spread': '2.86', 'groupId': 'OG002'}]}]}, {'title': 'Standard2', 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'Standard6', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Standard36', 'categories': [{'measurements': [{'value': '0.16', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Deviant2', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '1.73', 'groupId': 'OG002'}]}]}, {'title': 'Deviant6', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Deviant36', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '-2.55', 'spread': '2.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': "Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. MMN is measured while listening to a series of auditory tones, and is derived as the difference in responses to common stimuli minus rare stimuli (e.g., stimuli presented 90% of the time minus stimuli presented 10% of the time). A more negative value indicates stronger MMN, a more positive value indicates a stronger Repetition Positivity (RP) to the Standard stimuli, and a more negative value indicates a stronger Deviant Negativity (DN) to the Deviant stimuli. The investigators examined the deviant negativity, repetition positivity, and the MMN (which is defined as the difference between the standard-deviant), at three different standard tone repetition sequences (2, 6, or 36). In each case, the RP, DN, and MMN get stronger (i.e., larger amplitude) as the number of standard repetitions (2, 6, 36) increase.", 'unitOfMeasure': 'microvolts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Long-Term Potentiation (LTP) Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'classes': [{'title': 'Pre-tetanization', 'categories': [{'measurements': [{'value': '0.295', 'spread': '1.758', 'groupId': 'OG000'}, {'value': '0.201', 'spread': '1.530', 'groupId': 'OG001'}, {'value': '0.274', 'spread': '1.554', 'groupId': 'OG002'}]}]}, {'title': 'Post-tetanization 1', 'categories': [{'measurements': [{'value': '1.215', 'spread': '1.601', 'groupId': 'OG000'}, {'value': '1.145', 'spread': '1.217', 'groupId': 'OG001'}, {'value': '1.149', 'spread': '1.316', 'groupId': 'OG002'}]}]}, {'title': 'Post-tetanization 2', 'categories': [{'measurements': [{'value': '0.677', 'spread': '1.489', 'groupId': 'OG000'}, {'value': '0.360', 'spread': '1.563', 'groupId': 'OG001'}, {'value': '0.662', 'spread': '1.319', 'groupId': 'OG002'}]}]}, {'title': 'Post-tetanization 3', 'categories': [{'measurements': [{'value': '0.475', 'spread': '1.803', 'groupId': 'OG000'}, {'value': '0.226', 'spread': '1.722', 'groupId': 'OG001'}, {'value': '0.540', 'spread': '1.508', 'groupId': 'OG002'}]}]}, {'title': 'Pre-NonTetanized', 'categories': [{'measurements': [{'value': '0.207', 'spread': '0.664', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '1.378', 'groupId': 'OG001'}, {'value': '0.049', 'spread': '1.203', 'groupId': 'OG002'}]}]}, {'title': 'Post-NonTetanized 1', 'categories': [{'measurements': [{'value': '0.557', 'spread': '0.978', 'groupId': 'OG000'}, {'value': '0.197', 'spread': '1.217', 'groupId': 'OG001'}, {'value': '0.508', 'spread': '1.271', 'groupId': 'OG002'}]}]}, {'title': 'Post-NonTetanized 2', 'categories': [{'measurements': [{'value': '0.465', 'spread': '0.951', 'groupId': 'OG000'}, {'value': '0.364', 'spread': '1.515', 'groupId': 'OG001'}, {'value': '0.334', 'spread': '1.408', 'groupId': 'OG002'}]}]}, {'title': 'Post-NonTetanized 3', 'categories': [{'measurements': [{'value': '0.325', 'spread': '0.857', 'groupId': 'OG000'}, {'value': '0.705', 'spread': '1.303', 'groupId': 'OG001'}, {'value': '0.142', 'spread': '1.054', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'This LTP task compares visual evoked potentials (VEPs) derived from the EEG before and after a period of extended visual stimulation (tetanization). We measured VEP amplitudes to two different checkerboard patterns before (pre-) and at three time points after (post-) a 10-minute prolonged tetanization checkerboard. VEPs were measured to tetanized (i.e., the same stimuli used in the 10-minute tetanization) or not tetanized (a different checkerboard pattern than the one used in tetanization) stimuli, prior to baseline (pre-), and at 5- (Post 1), 10- (Post 2), and 15- (Post 3) minutes after tetanization. This resulted in 4 VEP measurements for each tetanized and non-tetanized checkerboard. We focused on relative changes from baseline for evidence of plasticity and input specificity (i.e., tetanized vs. non-tetanized stimuli) at each of the 3 post-tetanization time points.', 'unitOfMeasure': 'microvolt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurocognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.13', 'spread': '15.18', 'groupId': 'OG000'}, {'value': '45.32', 'spread': '11.34', 'groupId': 'OG001'}, {'value': '46.29', 'spread': '12.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'The MATRICS Consensus Cognitive Battery (MCCB) measures cognition in seven different domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) and provides a SINGLE summary t-score (age and gender corrected) of overall cognitive functioning. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Empathic Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People with mild to moderate diagnosis of TBI'}, {'id': 'OG002', 'title': 'Healthy Control', 'description': 'Participants without schizophrenia or any psychotic disorder, and without a TBI'}], 'timeFrame': '1 Day', 'description': "Participants watch 9, short video clips of a person recounting a personal story. The participant must continuously rate how the person in the video is feeling while telling the story. The participant's ratings are then correlated with the ratings of the person who was in the video rating how they felt recounting their story. The average correlation for the 9 videos is the dependent variable, with higher positive correlations indicating higher empathic accuracy.", 'reportingStatus': 'POSTED', 'populationDescription': 'We are unable to analyze the data due to an error in the scoring script that is not fixable.'}, {'type': 'SECONDARY', 'title': 'Community Integration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'classes': [{'title': 'CIQ-home', 'categories': [{'measurements': [{'value': '5.88', 'spread': '3.046', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '2.870', 'groupId': 'OG001'}, {'value': '6.67', 'spread': '2.461', 'groupId': 'OG002'}]}]}, {'title': 'CIQ-social', 'categories': [{'measurements': [{'value': '7.24', 'spread': '2.332', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '2.385', 'groupId': 'OG001'}, {'value': '8.96', 'spread': '2.116', 'groupId': 'OG002'}]}]}, {'title': 'CIQ-activities', 'categories': [{'measurements': [{'value': '3.00', 'spread': '1.581', 'groupId': 'OG000'}, {'value': '4.36', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '1.574', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'Community integration will be assessed by administering the Community Integration Questionnaire, which has 3 sub-scores (home, social, and activities). A higher score indicates better community integration.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A higher score indicates better functioning. CIQ-home ranges from 0-10, CIQ-social ranges from 0-12, and CIQ-activities ranges from 0-17.'}, {'type': 'SECONDARY', 'title': 'Ekman Facial Affect Identification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'OG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '44.6', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'Participants view a series of 56 faces depicting one of seven different emotions (happy, sad, surprised, angry, afraid, disgusted, and neutral). The total number correctly identified faces is the outcome measure, with higher scores indicating better performance. Scores range from 0-56, with 56 indicating 100% accurate facial affect identification.', 'unitOfMeasure': 'score on a scale (total out of 56)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'FG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'FG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'People With Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls."}, {'id': 'BG001', 'title': 'People With TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'BG002', 'title': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.\n\nElectroencephalography: The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '48.4', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-26', 'size': 506620, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-26T14:14', 'hasProtocol': True}, {'date': '2020-12-15', 'size': 1538569, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-03T12:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will have the same tasks delivered in the same manner.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2019-06-14', 'resultsFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-15', 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mismatch Negativity (MMN) Amplitudes in Microvolts', 'timeFrame': '1 Day', 'description': "Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. MMN is measured while listening to a series of auditory tones, and is derived as the difference in responses to common stimuli minus rare stimuli (e.g., stimuli presented 90% of the time minus stimuli presented 10% of the time). A more negative value indicates stronger MMN, a more positive value indicates a stronger Repetition Positivity (RP) to the Standard stimuli, and a more negative value indicates a stronger Deviant Negativity (DN) to the Deviant stimuli. The investigators examined the deviant negativity, repetition positivity, and the MMN (which is defined as the difference between the standard-deviant), at three different standard tone repetition sequences (2, 6, or 36). In each case, the RP, DN, and MMN get stronger (i.e., larger amplitude) as the number of standard repetitions (2, 6, 36) increase."}, {'measure': 'Visual Long-Term Potentiation (LTP) Task', 'timeFrame': '1 Day', 'description': 'This LTP task compares visual evoked potentials (VEPs) derived from the EEG before and after a period of extended visual stimulation (tetanization). We measured VEP amplitudes to two different checkerboard patterns before (pre-) and at three time points after (post-) a 10-minute prolonged tetanization checkerboard. VEPs were measured to tetanized (i.e., the same stimuli used in the 10-minute tetanization) or not tetanized (a different checkerboard pattern than the one used in tetanization) stimuli, prior to baseline (pre-), and at 5- (Post 1), 10- (Post 2), and 15- (Post 3) minutes after tetanization. This resulted in 4 VEP measurements for each tetanized and non-tetanized checkerboard. We focused on relative changes from baseline for evidence of plasticity and input specificity (i.e., tetanized vs. non-tetanized stimuli) at each of the 3 post-tetanization time points.'}], 'secondaryOutcomes': [{'measure': 'Neurocognition', 'timeFrame': '1 Day', 'description': 'The MATRICS Consensus Cognitive Battery (MCCB) measures cognition in seven different domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) and provides a SINGLE summary t-score (age and gender corrected) of overall cognitive functioning. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.'}, {'measure': 'Empathic Accuracy', 'timeFrame': '1 Day', 'description': "Participants watch 9, short video clips of a person recounting a personal story. The participant must continuously rate how the person in the video is feeling while telling the story. The participant's ratings are then correlated with the ratings of the person who was in the video rating how they felt recounting their story. The average correlation for the 9 videos is the dependent variable, with higher positive correlations indicating higher empathic accuracy."}, {'measure': 'Community Integration', 'timeFrame': '1 Day', 'description': 'Community integration will be assessed by administering the Community Integration Questionnaire, which has 3 sub-scores (home, social, and activities). A higher score indicates better community integration.'}, {'measure': 'Ekman Facial Affect Identification', 'timeFrame': '1 Day', 'description': 'Participants view a series of 56 faces depicting one of seven different emotions (happy, sad, surprised, angry, afraid, disgusted, and neutral). The total number correctly identified faces is the outcome measure, with higher scores indicating better performance. Scores range from 0-56, with 56 indicating 100% accurate facial affect identification.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Traumatic Brain Injury', 'Neuroplasticity', 'EEG'], 'conditions': ['Schizophrenia', 'Traumatic Brain Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://greenlab.dgsom.ucla.edu', 'label': 'The Green Lab'}]}, 'descriptionModule': {'briefSummary': "This proposal will examine measures of neuroplasticity (the brain's ability to alter its function or structure in response to changes in the environment or novel experiences) in Veterans with schizophrenia or traumatic brain injury (TBI). Both conditions are associated with impaired cognition (for example, attention, memory, learning), which is in turn associated with poor community functioning and integration. However, the two disorders differ in their origins: schizophrenia is a neurodevelopmental disorder appearing usually in late adolescence while TBI is an acquired disorder as the result of an injury to the head. Understanding of the root causes of complex cognitive impairments associated with these disorders remains limited. Neuroplasticity is a fundamental brain process that underlies cognitive functioning and may give insight into the causes of cognitive dysfunction in TBI and schizophrenia. Neuroplasticity will be measured using electroencephalography (EEG) by placing small electrodes on the scalp that record the brain's electrical activity. Participants will listen to simple auditory tones and view simple visual patterns while their EEG is recorded. Additionally, participants will have measures of cognition and clinical interviews for diagnosis of a disorder as well as any current levels of symptoms.", 'detailedDescription': 'EEG recording: In this procedure, the participant\'s brain function will be recorded while listening to auditory tones or viewing simple visual stimuli. Participants will respond with a button press to specific tones or images. Participants will have all tasks clearly described to them and will practice each task prior to beginning the experiments. While performing these tasks, the brain\'s electrical activity (commonly referred to as "brain waves") will be recording using electroencephalography (EEG). Participant\'s will wear a cap that contains several electrodes (small, metal discs that are able to pick up electrical activity). A small amount of gel will be applied to the scalp underneath each electrode. These electrodes simply rest on the surface of the scalp and above and below the left eye. It takes approximately 15 minutes to place and prepare the electrodes. The entire recording session will last approximately 90 minutes (including setup). Before having EEG recorded it is important to wash the hair and scalp and not use conditioners or products in the hair as these may interfere with the electrical signal. The gel used is simply washed out of the hair with running water.\n\nDuring the auditory task, participants will listen to a series of tones while watching a silent movie. Participants do not need to pay attention to the tones. During the visual task, participants will view a series of images on a computer screen that consist of a checkerboard pattern. Periodically, they will be asked to respond with a button press if one of the images is different than the others.\n\nInterviews: There will be interviews conducted by trained staff that ask questions about participants\' demographics (age, gender, education). A clinical interview will be given to all participants to determine if participants have either schizophrenia, a history of a traumatic brain injury, or have no psychiatric illness. All participants will be asked questions about how they are feeling. In addition, participants will answer questions about their family and friends and how they have been getting along with people in their lives.\n\nBehavioral testing: Participants will have measures of cognition assessed using various computer-based tasks and pen-and-pencil questionnaires. These tests assess aspects of cognition including memory, attention, language, and motor skills. Participants will also be asked to view a series of pictures of faces and identify the emotion depicted on the face. Finally, participants will be asked to view a series of short videos consisting of a person telling a personal story. Participants will continuously rate how they think that person in the video is feeling (happy, sad, angry, etc.) while telling their story.\n\nAdditional Information: It may sometimes be necessary to contact a participant\'s physician to inquire about their medical history or diagnosis. Permission will be sought from participant\'s in order for contact to be made with their physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans with a diagnosis of schizophrenia or a history of mild or moderate traumatic brain injury (TBI)\n* Veterans without a psychiatric diagnosis and no history of TBI (healthy control participants) will also be recruited\n* No other neurological or medical condition interfering with providing informed consent or valid assessment\n* No current depression based on the Structured Clinical Interview for DSM-5 (SCID-I) or depressive symptoms rated moderate or higher\n\n * a rating of 13 or higher on the Hamilton Depression Rating Scale\n* No DSM-V substance use disorder greater than mild severity in the past 3 months\n* No form of cognitive remediation in the 6 months prior to testing\n* An 8th grade reading level assessed with the Wide Range Achievement Test (WRAT)\n* Normal or corrected-to-normal vision and hearing\n\nExclusion Criteria:\n\nExclusion criteria for all patient participants include:\n\n* changes in medication dosage or type 3 months prior to testing\n* hospitalization for psychiatric health in the 3 months prior to testing\n* changes in housing status in the 6 months prior to testing'}, 'identificationModule': {'nctId': 'NCT03995368', 'acronym': 'NVEST', 'briefTitle': 'Neuroplasticity in TBI and Schizophrenia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'New Applications of Neuroplasticity Biomarkers in Veterans With Traumatic Brain Injury or Schizophrenia', 'orgStudyIdInfo': {'id': 'D3171-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'People with Schizophrenia', 'description': "People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.", 'interventionNames': ['Other: Electroencephalography']}, {'type': 'EXPERIMENTAL', 'label': 'People with TBI', 'description': 'People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.', 'interventionNames': ['Other: Electroencephalography']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'description': 'People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.', 'interventionNames': ['Other: Electroencephalography']}], 'interventions': [{'name': 'Electroencephalography', 'type': 'OTHER', 'otherNames': ['EEG'], 'description': 'The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.', 'armGroupLabels': ['Healthy Controls', 'People with Schizophrenia', 'People with TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073-1003', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}], 'overallOfficials': [{'name': 'Jonathan Wynn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}