Novel EEG Coherence Biomarkers for PTSD Assessment

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

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

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS)

Detailed Description

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:

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
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730-1114
      • VA Bedford HealthCare System, Bedford, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• 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.

Description

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)
  • Current or recent (within 1 month of study entry) DSM-5 substance use disorder
  • Individuals who are taking either illicit or prescribed Rx that could interfere with EEG, including benzodiazepines and certain mood stabilizers (e.g., Lithium)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTSD Undergoing Psycho-therapy; Veterans with PTSD seeking treatment and undergoing psycho-therapy	Behavioral: Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS); ACT is an evidence-based treatment that focuses on identifying a person's valued life goals and explicitly targets experiential avoidance to assist clients in committing to behavior change aligned with their values and becoming more psychologically flexible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coherence	Coherence describes the degree of electrical activity (EEG) synchrony among brain regions. Coherence is equivalent to correlation coefficient in frequency domain and takes values from 0 (no synchrony) to 1 (perfect synchrony). A detailed description of this method is provided in: Modarres M, Cochran D, Kennedy DN, Frazier JA. Comparison of comprehensive quantitative EEG metrics between typically developing boys and girls in resting state eyes-open and eyes-closed conditions.	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Portland VA Medical Center
• Investigators: Principal Investigator: Mo Modarres, PhD, VA Bedford HealthCare System, Bedford, MA

Publications and helpful links

General Publications

• Modarres M, Cochran D, Kennedy DN, Frazier JA. Comparison of comprehensive quantitative EEG metrics between typically developing boys and girls in resting state eyes-open and eyes-closed conditions. Front Hum Neurosci. 2023 Nov 6;17:1237651. doi: 10.3389/fnhum.2023.1237651. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: D2846-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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