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Novel EEG Coherence Biomarkers for PTSD Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209387
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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

Condition or disease
PTSD

Detailed 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 (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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
Control
No PTSD, TBI, and Depression
PTSD
Veterans ith PTSD



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans who have been previously deployed and meet diagnostic criteria for PTSD. Prior traumatic experience(s) does not have to be direct combat (e.g. may include search and rescue of combat operations). Persons previously treated for PTSD will be eligible so long as current diagnostic criteria are present.
Criteria

Inclusion Criteria:

  • Veterans who have been previously deployed and meet diagnostic criteria for PTSD. Prior traumatic experience(s) does not have to be direct combat (e.g. may include search and rescue of combat operations). Persons previously treated for PTSD will be eligible so long as current diagnostic criteria are present. Specific inclusion criteria are as follows:

    • Current (past month) diagnosis of PTSD as determined from the 30-item CAPS (score >45).
    • History of deployment and combat-related exposure stated as the principal reason for seeking treatment (based on self-report).
    • Ability to read and speak English to complete surveys and participate in therapy.
    • Explicit denial of suicidal or homicidal ideation or intent, which will be corroborated by reviewing the patient chart.

Exclusion Criteria:

  • Brain injury prohibiting speech, writing, and purposeful actions.
  • Identified to have current suicidal or homicidal ideation (immediate referral to a crisis center/hospital).
  • Major confounding psychiatric disorder; i.e. assessment indicates presence of:

    • Major mental health disorder that involves psychosis
    • Otherwise in the state of psychological crisis (appropriate referral to occur)
    • Currently undergoing substance abuse treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209387


Contacts
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Contact: Mo Modarres, PhD (781) 687-8984 Mo.Modarres@va.gov

Locations
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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         
Sponsors and Collaborators
VA Office of Research and Development
Portland VA Medical Center
Investigators
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Principal Investigator: Mo Modarres, PhD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04209387    
Other Study ID Numbers: D2846-R
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No