Novel EEG Coherence Biomarkers for PTSD Assessment

PTSD Clinical Trial

Official title: Neurophysiology Markers of PTSD's Presence, Severity and Therapy Outcome

Status Active, not recruiting

Clinical Trial Summary

Current practice for diagnosing and managing PTSD relies primarily on subjective clinical assessments by clinicians as well as patient self-report. An independent, objective and neuro-physiology based method for directly assessing brain function is not available, but is much needed to improve diagnosis and management of PTSD. To address this critical need, the investigators propose to test a set of novel biomarkers which are based on measures of coherent activity among the regions of cerebral cortex during sleep. In preliminary studies on EEG acquired during sleep from Veterans with PTSD alone as well as other co-morbidities, the investigators have shown that the neuromarkers were highly sensitive/specific to the presence of PTSD, and highly sensitive to the severity of symptoms in PTSD group. The overall goal of this project is to further validate these novel neurophysiology marker in retrospective and prospective studies

Clinical Trial Description

The project involves 3 types of research studies :

Study 1. This is a retrospective study where the Neuromarker analyses will be applied to a large existing database (n=656) containing sleep EEG recordings along with health and functional outcome measures, from Veterans with PTSD only (n=107), TBI only (n=126), both PTSD and TBI (n=87), depression only (n=80), and controls (no PTSD/TBI/Depression; n=256).

Study 2. This is a prospective study with n=10 Veterans with PTSD and n=10 controls to evaluate potential improvement on the performance of the Neuromarkers using a dense array (up to 64) EEG montage.

Study 3. This is a prospective study with PTSD (n=50) at multiple times during the Veterans ongoing clinical treatment for PTSD. sleep EEG measures will be collected at pretreatment, after first session of therapy, immediately after completion of therapy, and at 3-month post therapy.

Methodology:

For retrospective Study 1, the investigators will evaluate the performance of the PTSD neuromarker, in terms of sensitivity/ specificity/accuracy, utilizing a database of n=656 Veterans who have previously enrolled in the VA Portland Health Care System Sleep Laboratory Data Repository. The data repository contains sleep polysomnography (PSG) recordings (EEG and cardiorespiratory parameters), demographic information, medical history, and the following validated surveys (1) Epworth Sleepiness Scale, (2) NIH PROMIS, (3) Insomnia Severity Index, (4) Functional Outcomes of Sleep, (5) Patient Health Questionnaire, (6) PTSD symptoms checklist (PCL-5).

For prospective study 1, the investigators will perform sleep-EEG studies in n=10 PTSD and n=10 control subjects using a 64 channel EEG montage and will compare the performance of the neuromarkers, in distinguishing PTSD from non-PTSD groups, with the accuracy of diagnosis using only six EEG electrodes as performed in Study 1.

For prospective study 2, n=50 Veterans with PTSD symptoms undergoing the Veterans clinical treatment at the Bedford VA will be recruited and the following data will be acquired: Sleep-EEG, Demographic, Medical History, and Use of Medications forms, The Beck Depression Inventory, Pittsburgh Sleep Quality Index, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, NIH PROMIS, PCL-5, and Clinician-Administered PTSD Scale (CAPS-5). Primary independent variable will be changes in the Neuromarker and the dependent variables will consist of the functional and quality of life measures. ;

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT04209387
• Study type: Observational
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Start date: February 1, 2021
• Completion date: December 31, 2024