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

Butler Hospital

Status

Completed

Conditions

Adults

Treatments

Device: Alpha-Stim AID cranial electrotherapy stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06203717

2091269

Details and patient eligibility

About

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 feelings of depression, 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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 56 years old

Volunteers

Accepts Healthy Volunteers

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.