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Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder

PostTraumatic Stress Disorder Clinical Trial

Official title:
Closed Loop Vagal Nerve Stimulation in Patients With Posttraumatic Stress Disorder

Clinical Trial Summary

The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.

Clinical Trial Description

The purpose of this project is to develop the fundamental physiological understanding of feedback controlled vagal nerve stimulation (VNS) using positron emission tomography (PET) brain imaging and blood biomarker measurement with stress in healthy individuals and individuals with PTSD. Healthy human subjects with a history of psychological trauma but without the diagnosis of a psychiatric disorder (Phase 1), and human subjects with a history of PTSD (Phase 2), undergo PET imaging of the brain in conjunction with VNS or a sham treatment during exposure to neutral scripts and scripts of personal traumatic events. Blood is drawn simultaneously for measurement of a variety of stress responsive biomarkers, including inflammatory markers and neurohormones. A second PET scan with biomarkers assesses the delayed effects of VNS. On two other days subjects undergo exposure to random stressors with VNS or sham in conjunction with measurement of stress biomarkers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02992899
Study type Interventional
Source Emory University
Contact
Status Completed
Phase Phase 3
Start date April 19, 2017
Completion date September 21, 2019
View Details
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