Cranial Electrotherapy for PTSD Prevention

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Neurological conditions, Suicidal ideation, Psychiatric hospitalization, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mascha van 't Wout-Frank, PhD

Principal Investigator

Butler Hospital

Eligibility Criteria

This trial is for adult firefighters who are interested in trying a home-based treatment to manage stress. They should be willing to use the Alpha-Stim AID device daily, track their fatigue and anxiety levels, possibly undergo MRI scans, and wear a heart rate and sleep quality monitor.

Inclusion Criteria

I am in good health or my chronic conditions are stable.

Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent

Active duty firefighter in Rhode Island, USA

Exclusion Criteria

I have not had brain-related health issues like tumors, strokes, seizures, dementia, or brain surgery.

I need hospital care for my mental health condition.

Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete four weeks of cranial electrotherapy stimulation (CES) at home, with daily assessments of fatigue and anxiety, and may undergo MRI scans before and after CES.

4 weeks

Daily self-assessments, 2 MRI visits (pre and post-treatment)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PTSD symptoms.

4 weeks

Treatment Details

Interventions

• Alpha-Stim AID cranial electrotherapy stimulation

Trial Overview The study is testing if using the Alpha-Stim AID cranial electrotherapy stimulation device at home is doable and helpful for firefighters. It looks at how this treatment might affect their stress levels by measuring changes in fatigue, anxiety, brain function, heart rate, and sleep quality over four weeks.

Participant Groups

Group I: Alpha-Stim AID cranial electrotherapy stimulation Experimental Treatment 1 Intervention

Four-week course of noninvasive cranial electrotherapy stimulation.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Brown University

Collaborator

Trials

480

Recruited

724,000+

University of Rhode Island

Collaborator

Trials

57

Recruited

22,400+