Health TrialsbyHealthPanel

Neurophysiologic Biomarkers for Cognitive Rehabilitation

ConditionSchizophrenia Spectrum Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Veterans who are enrolled in and/or receiving healthcare services at the VA San Diego Healthcare System.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Neurophysiologic Biomarker Assessments

    Other intervention

    Non-invasive electroencephalography will be recorded to derive neurophysiologic biomarkers.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Biomarker Optimization - Patients1 intervention
Group B: Biomarker Optimization - Healthy Comparison Subjects1 intervention
Group C: Biomarker Validation in Chronic Psychotic Disorders1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Approximately 7 days

Secondary outcomes

1

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.

Time frame
Day 1/ Baseline
2

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.

Time frame
Day 1/ Baseline
3

Symptoms

Scores on the Positive and Negative Syndrome Scale (PANSS)

Time frame
1 visit
4

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).

Time frame
Day 1/ Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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