Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
- Conditions
- Adults
- Interventions
- Device: Alpha-Stim AID cranial electrotherapy stimulation
- Registration Number
- NCT06203717
- Lead Sponsor
- Butler Hospital
- Brief 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 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alpha-Stim AID cranial electrotherapy stimulation Alpha-Stim AID cranial electrotherapy stimulation Four-week course of noninvasive cranial electrotherapy stimulation.
- Primary Outcome Measures
Name Time Method Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions in four weeks 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 during four weeks (less than 20% attrition in the sample).
Intensity of anxiety assessed by VAS Daily throughout four weeks of cranial electrotherapy stimulation Intensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Number of completed cranial electrotherapy stimulation sessions in four weeks During and following four weeks of cranial electrotherapy stimulation 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).
- Secondary Outcome Measures
Name Time Method Intensity of feelings of fatigue assessed by VAS Daily throughout four weeks of cranial electrotherapy stimulation Intensity of subjective fatigue will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Structural neural connectivity assessed with magnetic resonance imaging Pre and post four weeks of cranial electrotherapy stimulation. Strength of structural connectivity between thalamus and cortical/subcortical regions will be assessed with magnetic resonance, diffusion tensor imaging
Severity of symptoms of posttraumatic stress disorder as measured with the PTSD Checklist for DMS 5 (PCL-5) Pre and post four weeks of cranial electrotherapy stimulation 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.
Functional resting state connectivity assessed with magnetic resonance imaging connectivity Pre and post four weeks of cranial electrotherapy stimulation 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.
Trial Locations
- Locations (1)
Butler Hospital
🇺🇸Providence, Rhode Island, United States