Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
- Conditions
- Schizophrenia
- Registration Number
- NCT04025502
- Lead Sponsor
- ERP Biomarker Qualification Consortium
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Power from the auditory steady-state response (ASSR) paradigm. 12-18 months Total Power (measured in µv2/Hz) will be collected during the ASSR paradigm as a primary endpoint.
Inter-trial coherence (ITC) from the auditory steady-state response (ASSR) paradigm. 12-18 months Inter-trial coherence (ITC) measured on a scale between 0 (no coherence) and 1 (maximum coherence) will be collected during the ASSR paradigm as a primary endpoint.
Relative Power for Pharmaco-EEG parameters per IPEG guidelines. 12-18 months Relative Power measured on a scale from 0 (no power in frequency band) to 1 (all EEG power in that frequency band) will be collected from the Resting State EEG as a primary endpoint for the following Pharmaco-EEG parameters:
* Delta power
* Theta power
* Alpha power
* Beta powerTask accuracy from the behavioral response during the active, auditory oddball ERP test. 12-18 months Task accuracy as a percentage of correct behavioral responses during the active, auditory oddball ERP test will be collected as a primary endpoint.
Reaction time from the behavioral response during the active, auditory oddball ERP test. 12-18 months Reaction time for the correct behavioral responses to the test measured in milliseconds will be collected as a primary endpoint during the active, auditory oddball ERP test.
Absolute Power for Pharmaco-EEG parameters per IPEG guidelines. 12-18 months Absolute Power (measured in µv2/Hz) will be collected from the Resting State EEG as a primary endpoint for the following Pharmaco-EEG parameters:
* Delta power
* Theta power
* Alpha power
* Beta power
* Gamma powerFunctional assessments as derived from the Positive and Negative Symptom Scale for Schizophrenia (PANSS). 12-18 months The PANSS items are divided into three sections: Positive symptoms, negative symptoms, and general symptoms. The following parameters will be collected:
PANSS Variable Ranges Description Range Low Range High Unit PANSS Items 1-30 1 7 n/a PANSS Total Score 30 210 n/aAmplitude (in microvolts) for parameters from the ERP tests. 12-18 months Amplitude (in microvolts) for the following parameters from the ERP tests will be collected as primary endpoints:
1. Passive, Tone-deviant, Auditory Oddball ERP
* N100
* MMN
* P3a
2. Passive, Duration-deviant, Auditory Oddball ERP
* N100
* MMN
* P3a
3. Active, Auditory Oddball ERP
* N100
* P3bLatency (in milliseconds) for parameters from the ERP tests. 12-18 months Latency (in milliseconds) for the following parameters from the ERP tests will be collected as primary endpoints:
1. Passive, Tone-deviant, Auditory Oddball ERP
* N100
* MMN
* P3a
2. Passive, Duration-deviant, Auditory Oddball ERP
* N100
* MMN
* P3a
3. Active, Auditory Oddball ERP
* N100
* P3bDominant frequency in the Alpha frequency band per IPEG guidelines 12-18 months Dominant frequency measured in Hz in the frequency interval between 6.0 and \< 12.5 Hz will be collected from the Resting State EEG as a primary endpoint.
Theta/Beta ratio and Slow Wave index per IPEG guidelines. 12-18 months Theta/Beta ratio and Slow Wave index (Alpha/Delta+Theta) measured in percentage will be collected from the Resting State EEG as primary endpoints.
Functional assessments as derived from the Brief Assessment of Cognition in Schizophrenia (BACS). 12-18 months The following parameters will be collected for the BACS:
BACS Variable Ranges Description Range Low Range High Unit Verbal Memory Total Score 0 75 n/a Digit Sequencing 0 28 n/a Token Motor Total Correct 0 100 n/a Verbal Fluency Total 0 100 n/a Symbol Coding 0 110 n/a Tower of London 0 22 n/a Verbal Memory T-Score -100 100 n/a Digit Sequencing T-Score -100 100 n/a Token Motor T-Score -100 100 n/a Verbal Fluency T-Score -100 100 n/a Symbol Coding T-Score -100 100 n/a Tower of London T-Score -100 100 n/aFunctional assessments as derived from the Virtual Reality Functional Capacity Assessment Tool (VRFCAT). 12-18 months The following parameters for the VRFCAT will be collected:
VRFCAT Variable Ranges Description Range Low Range High Unit VRFCAT- Adjusted Total Time 0 60000 msec VRFCAT- Total Error Count 0 60 n/a VRFCAT- Total Forced Progressions 0 12 n/a Adjusted Total Time T-Score -100 100 n/a Total Errors T-Score -100 100 n/a Total Forced Progressions T-Score -100 100 n/a
- Secondary Outcome Measures
Name Time Method Correlations between EEG/ERP measures and psychometric measures in Schizophrenia subjects. 12-18 months Pearson Correlation coefficients between EEG/ERP measures and scores from the functional assessments (BACS, PANSS, and VRFCAT) will be collected as secondary outcome measures.
Trial Locations
- Locations (3)
Collaborative Neuroscience Network, LLC
🇺🇸Torrance, California, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
Collaborative Neuroscience Network, LLC🇺🇸Torrance, California, United States