Trial Outcomes & Findings for Novel EEG Coherence Biomarkers for PTSD Assessment (NCT NCT04209387)

NCT ID: NCT04209387

Last Updated: 2025-11-25

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

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

Results posted on

2025-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Veterans With PTSD Undergoing Therapy Veterans with PTSD diagnosis undergoing psychotherapy tested at 3 time points, (1) before initiation of therapy, (2) at the end of therapy, (3) 3-months follow-up
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel EEG Coherence Biomarkers for PTSD Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veterans With PTSD Undergoing Therapy n=26 Participants PTSD undergoing therapy to be studies before and after treatment
Age, Categorical <=18 years	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants
Age, Continuous	47 years STANDARD_DEVIATION 13.7 • n=45 Participants
Sex: Female, Male Female	4 Participants n=45 Participants
Sex: Female, Male Male	22 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	10 Participants n=45 Participants
Race (NIH/OMB) White	11 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=45 Participants
Region of Enrollment United States	26 participants n=45 Participants
Coherence	0.28 Coherence STANDARD_DEVIATION 0.02 • n=45 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PTSD Veterans Undergoing Psychotherap n=26 Participants Baseline (Before initiation of therapy)
Coherence Baseline (Before Initiation of Therapy	0.28 Coherence Standard Deviation 0.02
Coherence End ot Therapy	0.27 Coherence Standard Deviation 0.02
Coherence 3-Month Follow-up	0.27 Coherence Standard Deviation 0.27

Adverse Events

Veterans With PTSD Undergoing Psychotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mo Modarres, PhD

VA Bedford Healthcare System

Phone: 2164966169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place