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NCT04209387 · ClinicalTrials.gov registry record

Novel EEG Coherence Biomarkers for PTSD Assessment

A clinical trial of PTSD, sponsored by VA Office of Research and Development.

Completed
Registry status
26
Enrollment target
1
Study location

NCT04209387 is a study of PTSD that has completed, run by VA Office of Research and Development. The registered enrollment target is 26 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04209387, a study of PTSD, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
26 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

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

Study Locations (1)

Massachusetts

  • VA Bedford HealthCare System, Bedford, MA - Bedford

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-02-01
Est. Completion 2024-12-31

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT04209387

The ClinicalTrials.gov registry entry for NCT04209387 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (91% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS) is the first listed.

NCT04209387 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04209387 about?

NCT04209387 is a clinical study titled "Novel EEG Coherence Biomarkers for PTSD Assessment". 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 diagno...

What is the current status of trial NCT04209387?

This trial is currently completed. The enrollment target is 26 participants. The study started on 2021-02-01. Estimated completion is 2024-12-31.

What conditions does trial NCT04209387 study?

This clinical trial studies the following conditions: PTSD.

What interventions are being tested in trial NCT04209387?

The interventions under investigation include: Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04209387?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04209387 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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