Adults Clinical Trial
Official title:
Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
Verified date | April 2024 |
Source | Butler Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 56 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Butler Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Butler Hospital | Brown University, University of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 |
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