Neurophysiologic Biomarkers for Cognitive Rehabilitation

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05945602
Status
Recruiting

Conditions

  • Schizophrenia Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Neurophysiologic Biomarker Assessments — OTHER
    Non-invasive electroencephalography will be recorded to derive neurophysiologic biomarkers.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Biomarker Optimization - Patients
    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).
  • Arm: Biomarker Optimization - Healthy Comparison Subjects
    Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System who have no history of mental illness.
  • Arm: Biomarker Validation in Chronic Psychotic Disorders
    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).

Primary Outcome Measure

1-week psychometric reliability of Aperiodic Spectral Biomarkers (neurophysiologic biomarker) [ Time Frame: Approximately 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Juan Molina, MD
(202) 555-8975
Juan Molina, MD (PRINCIPAL_INVESTIGATOR)

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