[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05945602":3,"trial-entities:NCT05945602":97,"trial-summary:NCT05945602":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":91,"overall_officials":93,"references":95,"see_also_links":96},"NCT05945602","D4570-W","Neurophysiologic Biomarkers for Cognitive Rehabilitation","Optimization of Neurophysiologic Biomarkers for Rehabilitation Interventions in Veterans With Chronic Psychosis","RECRUITING","2028-09-30","2025-10","2025-10-09","2023-10-01","VA Office of Research and Development","FED",false,"Cognitive symptoms of schizophrenia interfere with daily life-from managing self-care, to more complex tasks like taking medications and living independently. Unfortunately, these cognitive symptoms are not corrected by 'standard of care' treatments (antipsychotic medications), although some schizophrenia patients may experience modest clinical and cognitive benefits from cognitive remediation. To enhance the clinical impact of cognitive remediation and other rehabilitative interventions for Veterans living with chronic psychosis, this study will develop novel brain-based tools to help identify those Veterans who are most likely to benefit from pro-cognitive therapies. These studies may advance predictive algorithms that improve functional outcomes and life quality in Veterans with schizophrenia.","This is an observational study recruiting Veterans with a diagnosis of Schizophrenia (SZ) and other Chronic Psychotic Disorders and Veterans in good general health (HS) who are enrolled in and\u002For receiving care at the VA San Diego Healthcare System. Eighty Veterans will undergo comprehensive neurophysiological, clinical, cognitive, and functional assessments in two \"phases\" (Phase 1: 30 SZ, 20 HS; Phase 2: 30 SZ).\n\nIn Phase 1 (Biomarker Optimization; Aims 1 \\& 2), Veterans will undergo systematic neurophysiologic testing designed to elicit spectral biomarkers linked to cortical excitation and inhibition (\"E\u002FI balance\") during passive and stimulated conditions on two separate test visits (1-2 weeks apart). Experimental conditions will then be optimized for internal consistency and test-retest reliability using Generalizability Theory. The optimized biomarkers will be carried forward into Phase 2 (Biomarker Validation; Aim 3), where these neurophysiologic measures will be assessed before and after Veterans with SZ undergo 1 hour of cognitive training as a demonstration of neural system target engagement.\n\nThis proposal has 3 specific aims:\n\nAim 1. Identify the experimental conditions that optimize the psychometric properties (i.e., sensitivity to detect individual differences) of the spectral biomarkers linked to E\u002FI balance.\n\nAim 2. Characterize the relationships of spectral biomarkers with rehabilitation-relevant outcomes.\n\nAim 3. Evaluate the sensitivity of the optimized E\u002FI measures in predicting performance during an acute, 1-hour exposure to computerized cognitive training.",[19],"Schizophrenia Spectrum Disorders",[21,22,23],"Schizophrenia","Schizophrenia Spectrum and Other Psychotic Disorde","Mental Disorders","OBSERVATIONAL",null,[],{"count":28,"type":29},80,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"OTHER","Neurophysiologic Biomarker Assessments","Non-invasive electroencephalography will be recorded to derive neurophysiologic biomarkers.",[36,37,38],"Biomarker Optimization - Healthy Comparison Subjects","Biomarker Optimization - Patients","Biomarker Validation in Chronic Psychotic Disorders",[40],{"measure":41,"description":42,"timeFrame":43},"1-week psychometric reliability of Aperiodic Spectral Biomarkers (neurophysiologic biomarker)","Estimates of aperiodic activity will be calculated from electroencephalography recordings collected at baseline (Day 1) and approximately 7 days later.","Approximately 7 days",[45,49,52,56,59],{"measure":46,"description":47,"timeFrame":48},"Cognitive training performance","Performance on a computerized cognitive training exercise (i.e., the \"Sound Sweeps\" exercise) assessing auditory processing speed. Scores range between 0-1000, with greater scores indicating worse performance.","Day 1\u002F Baseline",{"measure":50,"description":51,"timeFrame":48},"Cognition","Performance on MATRICS Consensus Cognitive Battery (MCCB). MCCB performance will be evaluated based on age- and gender-corrected T-scores (normative mean = 50; standard deviation = 10). Higher T-score values indicate better performance.",{"measure":53,"description":54,"timeFrame":55},"Symptoms","Scores on the Positive and Negative Syndrome Scale (PANSS)","1 visit",{"measure":57,"description":58,"timeFrame":48},"Functioning","Scores on the World Health Organization Disability Assessment Schedule (WHODAS 2.0). WHODAS summary scores are converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).",{"measure":60,"description":61,"timeFrame":48},"Functioning - Quality of Life","Scores on the World Health Organization Quality of Life Scale (WHOQOL-BREF). WHOQOL-BREF domain scores are converted into a metric ranging from 0 to 100 (where 0 = very poor quality of life; 100 = very good quality of life).","ALL","18 Years","75 Years",true,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Have a DSM-5 diagnosis of a chronic psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or delusional disorder); or b) are in good general mental and physical health (i.e., no active mental health condition).\n2. Fluent in spoken and written English.\n3. No impairment in hearing or vision.\n\nExclusion Criteria:\n\n1. Active substance other than cannabis within the last 30 days as determined by self-report or positive urine toxicology (obtained as part of the screening process).\n2. History of significant medical or neurological illness or intellectual disability.\n3. Inability to comprehend or provide informed consent.\n4. Specific to healthy comparison subjects: past or present diagnosis of schizophrenia, schizoaffective disorder, or other chronic psychotic disorder.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":88},"VA San Diego Healthcare System, San Diego, CA","San Diego","California","92161-0002","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Juan Molina, MD","CONTACT","(202) 555-8975","Juan.Molina@va.gov",{"name":82,"role":87},"PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},32.71571,-117.16472,[92],{"name":82,"role":83,"phone":84,"email":85},[94],{"name":82,"affiliation":75,"role":87},[],[],{"nct_id":4,"conditions":98,"biomarkers":102},[99,100,101,21],"Delusional Disorder","Psychiatric Disorder","Schizoaffective Disorder",[],{"nct_id":4,"found":65,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study planning to enroll 80 Veterans, divided into two phases. It involves comparing Veterans with schizophrenia spectrum disorders to those in good general health.","completed","Observational Study on Neurophysiologic Biomarkers for Cognitive Rehabilitation in Schizophrenia Spectrum Disorders","This study is looking for Veterans aged 18 to 75 with schizophrenia spectrum disorders (like schizophrenia, schizoaffective disorder, or delusional disorder) or those in good general mental and physical health. The goal is to develop new brain-based tools to help identify which Veterans with chronic psychosis might benefit most from therapies that improve thinking skills. Researchers will use non-invasive electroencephalography (EEG, a test that measures brain waves) to find specific brain markers called \"Aperiodic Spectral Biomarkers.\" The study will assess the reliability of these biomarkers over about 7 days. This is an observational study, meaning you won't receive a new treatment, but researchers will gather information. The study plans to enroll 80 Veterans, but its current recruitment status is unclear.","The primary endpoint measures the reliability of biomarkers at approximately 7 days.",120,"You would undergo comprehensive neurophysiological, clinical, cognitive, and functional assessments. This includes systematic neurophysiologic testing on two separate visits, 1-2 weeks apart, and potentially 1 hour of cognitive training.","Not stated in the trial record.",[],"v2"]