Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
NCT06203717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-11-05
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.
Conditions
- Adults
Interventions
- 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.
Sponsors & Collaborators
-
University of Rhode Island
collaborator OTHER -
Brown University
collaborator OTHER -
Butler Hospital
lead OTHER
Principal Investigators
-
Mascha van 't Wout-Frank, PhD · Butler Hospital
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 56 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-29
- Primary Completion
- 2025-06-03
- Completion
- 2025-06-03
- FDA Device
- Yes
Countries
- United States
Study Locations
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