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Clinical Trial Summary

The goal of this study is to test whether active duty firefighters find it possible and suitable to do cranial electrotherapy stimulation (CES) at home, and test whether CES influences measures of stress. The main questions it aims to answer are: - is CES feasible and acceptable in a population of firefighters, and - does CES changes feelings of fatigue, anxiety, and brain connectivity in firefighters. Participants will - complete four weeks of CES at home, and - complete daily assessments of fatigue and anxiety, and maybe asked to - complete an MRI scan before and after CES, and - wear a device to measure their heart rate and sleep quality.


Clinical Trial Description

Despite an urgent need for interventions that can prevent the development of posttraumatic stress disorder (PTSD) in firefighter first responders who, due to the nature of their occupation, are at ultrahigh risk for PTSD and its profound consequences, current preventative approaches suffer from low rates of efficacy or difficulties with implementation. Cranial electrotherapy stimulation (CES), a noninvasive brain stimulation technique that is FDA approved for treatment of anxiety, insomnia, and depression, offers substantial promise as a proactive preventative intervention for PTSD because of its hypothesized ability to reestablish homeostasis, a process that becomes dysregulated in individuals who develop PTSD. The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct Centers of Biomedical Research Excellence to test whether four weeks of CES is feasible and acceptable in firefighters as well as obtain early signal of CES efficacy to change subjective and objective indices of homeostatic functioning to allow a long-term collaboration with the ultimate goal to develop a safe, effective, and easily deployable intervention to prevent PTSD in first responders. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06203717
Study type Interventional
Source Butler Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date April 29, 2024
Completion date January 31, 2025

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