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 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 fatigue, anxiety, and brain connectivity in firefighters.

Participants will

• complete four weeks of CES at home, and
• complete daily assessments of fatigue and anxiety, and maybe asked to
• complete an MRI scan before and after CES, and
• wear a device to measure their heart rate and sleep quality.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adults
• Intervention / Treatment: Device: Alpha-Stim AID cranial electrotherapy stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha-Stim AID cranial electrotherapy stimulation; Four-week course of noninvasive cranial electrotherapy stimulation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of completed cranial electrotherapy stimulation sessions in four weeks	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).	During and following four weeks of cranial electrotherapy stimulation
Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions in four weeks	Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks (less than 20% attrition in the sample).	During and following four weeks of cranial electrotherapy stimulation
Intensity of anxiety assessed by VAS	Intensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.	Daily throughout four weeks of cranial electrotherapy stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of feelings of fatigue assessed by VAS	Intensity of subjective fatigue will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.	Daily throughout four weeks of cranial electrotherapy stimulation
Structural neural connectivity assessed with magnetic resonance imaging	Strength of structural connectivity between thalamus and cortical/subcortical regions will be assessed with magnetic resonance, diffusion tensor imaging	Pre and post four weeks of cranial electrotherapy stimulation.
Severity of symptoms of posttraumatic stress disorder as measured with the PTSD Checklist for DMS 5 (PCL-5)	Presence and severity of posttraumatic stress disorder symptoms will be assessed before and after four weeks of CES 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.	Pre and post four weeks of cranial electrotherapy stimulation
Functional resting state connectivity assessed with magnetic resonance imaging connectivity	Strength of functional resting state connectivity between thalamus and (ventro)medial prefrontal cortex, hippocampus, posterior cingulate cortex, and precuneus will be assessed with functional resting state magnetic resonance imaging.	Pre and post four weeks of cranial electrotherapy stimulation

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: Brown University; University of Rhode Island
• Investigators: Principal Investigator: Mascha van 't Wout-Frank, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Firefighters
• Other Study ID Numbers: 2091269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No