Clinical trial NCT06203717: Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
Official title: Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adults
Keywords: Firefighters
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
name: Brown University
First posted: 2024-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of completed cranial electrotherapy stimulation sessions in four weeks
timeFrame: During and following four weeks of cranial electrotherapy stimulation
measure: Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions in four weeks
timeFrame: During and following four weeks of cranial electrotherapy stimulation
measure: Intensity of anxiety assessed by VAS
timeFrame: Daily throughout four weeks of cranial electrotherapy stimulation
Secondary outcomes:
measure: Intensity of feelings of fatigue assessed by VAS
timeFrame: Daily throughout four weeks of cranial electrotherapy stimulation
measure: Structural neural connectivity assessed with magnetic resonance imaging
timeFrame: Pre and post four weeks of cranial electrotherapy stimulation.
measure: Severity of symptoms of posttraumatic stress disorder as measured with the PTSD Checklist for DMS 5 (PCL-5)
timeFrame: Pre and post four weeks of cranial electrotherapy stimulation
measure: Functional resting state connectivity assessed with magnetic resonance imaging connectivity
timeFrame: Pre and post four weeks of cranial electrotherapy stimulation
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Mascha van 't Wout-Frank, PhD
role: PRINCIPAL_INVESTIGATOR
References: