Trial results for a study investigating novel EEG coherence biomarkers for Posttraumatic Stress Disorder (PTSD) were posted on ClinicalTrials.gov on 2025-11-25, reporting a significant p-value of 0.01 for changes in coherency among 26 enrolled participants.
Background
Current diagnostic and management practices for PTSD primarily rely on subjective clinical assessments and patient self-reports. There is a recognized need for an independent, objective, and neuro-physiology based method to directly assess brain function, which could significantly improve the diagnosis and management of PTSD. This study aimed to address this need by testing novel biomarkers derived from measures of coherent activity among regions of the cerebral cortex during sleep.
Trial design
This completed study enrolled 26 participants diagnosed with PTSD. The investigation focused on testing novel EEG coherence biomarkers during sleep. The participants were PTSD veterans undergoing psychotherapy, and the study aimed to assess changes in brain function objectively.
Key results
The trial reported several key measurements related to coherence:
- For PTSD Veterans Undergoing Psychotherapy, a mean coherence of 0.28 (Standard Deviation 0.02) was observed.
- Another mean coherence of 0.27 (Standard Deviation 0.02) was observed for the same group.
- A third mean coherence of 0.27 (Standard Deviation 0.27) was also reported for PTSD Veterans Undergoing Psychotherapy.
A key analysis using the Wilcoxon (Mann-Whitney) method reported a p-value of 0.01. This analysis involved pair-wise comparisons of changes in coherency from baseline (before therapy) to the end of therapy, and from the end of therapy to a 3-month follow-up.
What this means
The posted results suggest that novel EEG coherence biomarkers measured during sleep may offer an objective method for assessing brain function in individuals with PTSD. The statistically significant p-value of 0.01 from the Wilcoxon (Mann-Whitney) analysis indicates that changes in coherency occurred over the course of psychotherapy and follow-up, potentially serving as an objective indicator of treatment response or disease progression. These findings support the potential for neuro-physiology based methods to complement or enhance current subjective assessments in PTSD diagnosis and management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04209387, titled "Novel EEG Coherence Biomarkers for PTSD Assessment", were posted on 2025-11-25 on clinicaltrials.gov.