Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This is an observational, non-interventional study that will recruit Healthy Volunteers (HV)
      and subjects with clinically confirmed Schizophrenia (SZ). The purpose of this study is to
      establish the mean and variance across the HV and SZ cohorts, sites, and repeated tests of
      the electroencephalogram(EEG)/Event-related potentials (ERP) measures.
    

Detailed description: 
      Among the most replicated pathophysiological findings in schizophrenia is the impairment of
      Event-Related Potentials (ERPs) recorded during the auditory oddball procedure. In this
      procedure, time-locked electroencephalogram (EEG) responses are recorded during auditory
      processing of frequent and rare tones differing in pitch or duration. In addition, a smaller
      but substantial literature has reported deficits in the auditory steady-state EEG response
      (ASSR) to a 40 Hz train of auditory tones in subjects with schizophrenia versus healthy
      control subjects.

      While measurement of ERPs in the drug development setting has shown promise, the instruments,
      infrastructure, and standardization of these methods has lagged. New, portable, easy-to-use,
      Food and Drug Administration (FDA)-approved devices are now available for the automated
      collection and analysis of EEG and ERP data.

      This observational, non-interventional, clinical study will recruit healthy volunteer
      subjects (HV) and subjects with clinically confirmed schizophrenia (SZ), and will establish
      the mean and variance across HV and SZ cohorts, sites and repeated tests, of EEG and ERP
      measures collected with a standardized EEG/ERP device. The study will also examine the
      relationship between specific EEG/ERP features and measures of positive, negative, and
      cognitive symptoms and global function in SZ subjects.

      The data collected in this study is intended to replicate published observations of the
      magnitude of deficit in ERPs in SZ versus HV subjects, and to support the design of
      subsequent interventional studies that will make use of ERPs. Furthermore, these data will be
      submitted to support qualification of the ERP biomarkers through the FDA Drug Development
      Tools Biomarker Qualification Program.
    

Intervention name(s): Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
Intervention type(s): Device
Intervention description(s): The testing protocol consists of an auditory oddball Event-Related Potential (ERP) paradigm, 40Hz ASSR, and the collection of 6 minutes of resting electroencephalogram (EEG). During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 6 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 60-75 minutes.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        There will be four different sites where the participants will be selected in the following
        states: California, New Jersey, and New York.

        Recruitment methods:

          -  Database of individuals who have agreed to be contacted

          -  Advertisements

          -  Physician to physician referrals
      
Biospecimen description: 
      Saliva drug screen to rule out illicit drug use for all three visits (Screening visit,
      Baseline visit, and Retest visit).
    
Keywords: ERP; EEG; Event-related potential; MMN; Schizophrenia; Electroencephalogram; Mismatch Negativity; N100; P3a; P3b