Novel EEG Coherence Biomarkers for PTSD Assessment

NCT04209387 | Completed Results

• 1 other identifier: D2846-R
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS) BEHAVIORAL

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

PTSD Undergoing Psycho-therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Portland VA Medical Center: collaborator

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (1)

• 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.

  PMID: 38021243 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Mo Modarres, PhD
• Organization: VA Bedford Healthcare System

mmodarres@verizon.net

2164966169

Study Officials

• Mo Modarres, PhD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 24, 2019
• Study Start: February 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)