Novel EEG Coherence Biomarkers for PTSD Assessment

Part of paid clinical trials in Bedford, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT04209387
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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

Study Details

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

Key Dates

Start date
Feb 1, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
26 participants (actual)

Arms

  • Arm: PTSD Undergoing Psycho-therapy
    Veterans with PTSD seeking treatment and undergoing psycho-therapy

Primary Outcome Measure

Coherence [ 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Bedford HealthCare System, Bedford, MABedfordMassachusetts01730-1114-

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