NCT06203717

Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

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 depression and posttraumatic 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 depression, anxiety, and fatigue in firefighters. Participants will * complete four weeks of CES at home, and * complete daily assessments of affect and fatigue, and * complete self-reported symptoms of depression and posttraumatic stress before and after four weeks of CES at home Participants maybe asked to * complete an MRI scan before and after four weeks of CES at, and * wear a device to measure their heart rate and sleep quality.

Detailed 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.

Conditions

• Adults

Interventions

Type	Name	Description
DEVICE	Alpha-Stim AID cranial electrotherapy stimulation	Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2024-01-12
• Last updated: 2025-11-05
• Results posted: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study