Neurophysiologic Biomarkers for Cognitive Rehabilitation
- Conditions
- Schizophrenia Spectrum Disorders
- Interventions
- Other: Neurophysiologic Biomarker Assessments
- Registration Number
- NCT05945602
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
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/or 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).
In 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/I 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.
This proposal has 3 specific aims:
Aim 1. Identify the experimental conditions that optimize the psychometric properties (i.e., sensitivity to detect individual differences) of the spectral biomarkers linked to E/I balance.
Aim 2. Characterize the relationships of spectral biomarkers with rehabilitation-relevant outcomes.
Aim 3. Evaluate the sensitivity of the optimized E/I measures in predicting performance during an acute, 1-hour exposure to computerized cognitive training.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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).
- Fluent in spoken and written English.
- No impairment in hearing or vision.
- 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).
- History of significant medical or neurological illness or intellectual disability.
- Inability to comprehend or provide informed consent.
- Specific to healthy comparison subjects: past or present diagnosis of schizophrenia, schizoaffective disorder, or other chronic psychotic disorder.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Biomarker Optimization - Healthy Comparison Subjects Neurophysiologic Biomarker Assessments Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System who have no history of mental illness. Biomarker Validation in Chronic Psychotic Disorders Neurophysiologic Biomarker Assessments Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System with a diagnosis of a chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder). Biomarker Optimization - Patients Neurophysiologic Biomarker Assessments Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System who have a diagnosis of a chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
- Primary Outcome Measures
Name Time Method 1-week psychometric reliability of Aperiodic Spectral Biomarkers (neurophysiologic biomarker) Approximately 7 days Estimates of aperiodic activity will be calculated from electroencephalography recordings collected at baseline (Day 1) and approximately 7 days later.
- Secondary Outcome Measures
Name Time Method Cognitive training performance Day 1/ Baseline 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.
Functioning Day 1/ Baseline 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).
Symptoms 1 visit Scores on the Positive and Negative Syndrome Scale (PANSS)
Functioning - Quality of Life Day 1/ Baseline 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).
Cognition Day 1/ Baseline 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.
Trial Locations
- Locations (1)
VA San Diego Healthcare System, San Diego, CA
🇺🇸San Diego, California, United States