A Multi-Center Study of Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 3
- 主要终点
- Total Power from the auditory steady-state response (ASSR) paradigm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Total Power from the auditory steady-state response (ASSR) paradigm.
时间窗: 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.
时间窗: 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.
时间窗: 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 power
Task accuracy from the behavioral response during the active, auditory oddball ERP test.
时间窗: 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.
时间窗: 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.
时间窗: 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 power
Functional assessments as derived from the Positive and Negative Symptom Scale for Schizophrenia (PANSS).
时间窗: 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/a
Amplitude (in microvolts) for parameters from the ERP tests.
时间窗: 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 * P3b
Latency (in milliseconds) for parameters from the ERP tests.
时间窗: 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 * P3b
Dominant frequency in the Alpha frequency band per IPEG guidelines
时间窗: 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.
时间窗: 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).
时间窗: 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/a
Functional assessments as derived from the Virtual Reality Functional Capacity Assessment Tool (VRFCAT).
时间窗: 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
次要结局
- Correlations between EEG/ERP measures and psychometric measures in Schizophrenia subjects.(12-18 months)