Validation of a Suite of ERP and QEEG Biomarkers in a Pre-Competitive, Industry-Led Study in Subjects with Schizophrenia and Healthy Volunteers
24 Pages Posted: 16 Sep 2022
Objective: Complexity and lack of standardization have mostly limited the use of event-related potentials (ERPs) and quantitative EEG (QEEG) biomarkers in drug development to small early phase trials. We present results from a clinical study on healthy volunteers (HV) and patients with schizophrenia (SZ) that assessed group differences, variance, and correlation with functional assessments for ERP and QEEG parameters collected at commercial and clinical trial sites with standardized methods and analyzed through an automated data analysis pipeline.
Methods: 81 HV and 80 SZ were tested at one of four study sites. Study subjects were administered two ERP/EEG testing sessions on separate visits. Sessions included a mismatch negativity paradigm, a 40Hz auditory steady state response, an eyes-closed resting state EEG, and an active auditory oddball task. SZ subjects were also tested on the Brief Assessment of Cognition (BAC), the Positive and Negative Syndrome Scale (PANSS), and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT).
Results: Standardized ERP/EEG testing equipment and protocols ensured a low number of test failures. The automated data analysis pipeline allowed for near real-time assessment of results. Test-retest reliability was fair-to-excellent for most of the measures collected. SZ subjects showed significant deficits in ERP and QEEG parameters that were consistent with the published academic literature. A subset of ERP and QEEG parameters correlated with functional assessments administered to the SZ subjects.
Conclusions: With standardized equipment and methods, complex ERP/EEG testing sessions can be reliably performed at commercial and clinical study sites to produce high-quality data in near real-time.
Clinical Trial Registration Details: ClinicalTrials.gov number NCT04025502.
Funding Information: This research was funded by the ERP Biomarker Qualification Consortium.
Declaration of Interests: None.
Ethics Approval Statement: The study was approved by institutional review boards for each site. Written informed consent was obtained from each study participant, after which subjects were screened for eligibility.
Keywords: ERP Biomarker Qualification Consortium, Event Related Potentials, Quantitative EEG, schizophrenia, Test-Retest Reliability, Automated Data Analysis.
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