Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID05945602

Optimization of Neurophysiologic Biomarkers for Rehabilitation Interventions in Veterans With Chronic Psychosis

Led by VA Office of Research and Development · Updated on 2025-10-09

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to improve cognitive rehabilitation for Veterans living with chronic psychosis, including schizophrenia and related disorders. Cognitive symptoms in schizophrenia affect daily functioning and are not fully addressed by standard antipsychotic treatments. The study seeks to develop brain-based tools to identify which Veterans might benefit most from therapies targeting cognitive function, potentially leading to better life quality and functional outcomes. The study is observational and involves Veterans with chronic psychotic disorders as well as healthy Veterans in good general health. There are two phases: Phase 1 focuses on optimizing neurophysiologic biomarkers using electroencephalography (EEG) during two test visits spaced 1 to 2 weeks apart. Phase 2 validates these biomarkers by assessing their changes before and after one hour of computerized cognitive training in Veterans with schizophrenia. Participants will undergo detailed neurophysiological, clinical, cognitive, and functional assessments. Researchers will measure the reliability of brain biomarkers over one week, evaluate cognitive training performance, and assess symptoms and quality of life. The study includes screening for eligibility, multiple assessments, and uses EEG to record brain activity. Participation lasts through both phases with repeated evaluations to understand how brain measures relate to rehabilitation outcomes.

CONDITIONS

Brief Title

Neurophysiologic Biomarkers for Cognitive Rehabilitation

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a DSM-5 diagnosis of a chronic psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or delusional disorder) or be in good general mental and physical health without active mental health conditions
  • Fluent in spoken and written English
  • No impairment in hearing or vision
Not Eligible

You will not qualify if you...

  • Active substance use other than cannabis within the last 30 days based on self-report or urine toxicology
  • History of significant medical or neurological illness or intellectual disability
  • Inability to comprehend or provide informed consent
  • For healthy comparison subjects: past or present diagnosis of schizophrenia, schizoaffective disorder, or other chronic psychotic disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 to 2 weeks

Participants undergo comprehensive neurophysiological, clinical, cognitive, and functional assessments to identify neurophysiologic biomarkers.

2 visits (in-person) approximately 1 to 2 weeks apart

Monitoring

Duration - Single day

Participants with chronic psychotic disorders receive 1 hour of cognitive training with neurophysiologic measures assessed before and after to evaluate neural system target engagement.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

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Research Team

J

Juan Molina, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Frequently Asked Questions

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