CompletedNot Applicable

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

United States13 participantsStarted 2024-04-29

Plain-language 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 symptoms of posttraumatic stress and depression as well as feelings of 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.

Who can participate

Age range

18 Years – 56 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Active duty firefighter in Rhode Island, USA; * Age between 18 and 56 years old; * Be in good medical health or, if having chronic medical conditions, these conditions needed to be stable; * Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent. Exclusion Criteria: * MRI and CES-related contraindications, e.g., implanted metallic device or substances including pacemakers, cochlear implant, metallic tattoos, claustrophobia, pregnancy or planning to become pregnant during the study duration and nursing; * Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery; * Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months; * Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization; * Current moderate or severe alcohol or other substance abuse (excluding nicotine); * Major or unstable medical illness requiring further investigation or treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Cranial Electrotherapy Stimulation

Timeframe: During four weeks of cranial electrotherapy stimulation at-home use

Acceptability of Cranial Electrotherapy Stimulation

Timeframe: During four weeks of cranial electrotherapy stimulation

Trial details

NCT IDNCT06203717

SponsorButler Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-03

Results submitted2025-10-14

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