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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203717 on ClinicalTrials.gov