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Completed

NCT Number: NCT06203717

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

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.

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Key information

Conditions

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alpha-Stim AID cranial electrotherapy stimulation

Device

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.

Primary outcomes

  1. Feasibility of Cranial Electrotherapy Stimulation

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

    Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed).

  2. Acceptability of Cranial Electrotherapy Stimulation

    Time frame: During four weeks of cranial electrotherapy stimulation

    Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks

Secondary outcomes

  1. Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)

    Time frame: Post four weeks of cranial electrotherapy stimulation

    Score on the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms.

  2. Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)

    Time frame: post four weeks of cranial electrotherapy stimulation.

    Score on the Inventory of Depressive Symptomatology-Self Report (IDS-SR). The Inventory of Depressive Symptomatology-Self Report (IDS-SR) has a total score range of 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology.

  3. Intensity of Feelings of Fatigue

    Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported

    Intensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.

  4. Intensity of Feelings of Anxiety

    Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported

    Intensity of subjective anxiety assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University
  • University of Rhode Island

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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