N/A
N=26
Novel EEG Coherence Biomarkers for PTSD Assessment
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT04209387 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Coherence — 0.28; 0.27; 0.27 Coherence — p=0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coherence |
0.28; 0.27; 0.27 | 0.01 sig |
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
Eligibility 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)
- 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)
Data sourced from ClinicalTrials.gov (NCT04209387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.