Novel EEG Coherence Biomarkers for PTSD Assessment
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|ClinicalTrials.gov Identifier: NCT04209387|
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : June 9, 2020
|Condition or disease|
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 (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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Neurophysiology Markers of PTSD's Presence, Severity and Therapy Outcome|
|Estimated Study Start Date :||November 2, 2020|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
No PTSD, TBI, and Depression
Veterans ith PTSD
- EEG-based Neuromarker Change [ Time Frame: Pre-treatment (within one week of initiation of PTSD therapy), within one week before initiation of their treatment protocol, within one week after the conclusion of their treatment phase, and about three months after their last therapy session ]Neuromarkers computed from Coherence of brain activity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209387
|Contact: Mo Modarres, PhD||(781) 687-8984||Mo.Modarres@va.gov|
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|
|Bedford, Massachusetts, United States, 01730|
|Contact: Joseph Squicciarini 781-687-2926 Joe.Squicciarini@va.gov|
|Principal Investigator: Mo Modarres, PhD|
|Principal Investigator:||Mo Modarres, PhD||Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|