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Device

Cranial Electrotherapy for PTSD Prevention

N/A
Waitlist Available
Led By Mascha van 't Wout-Frank, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 56 years old
Be between 18 and 65 years old
Must not have
Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery
Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post four weeks of cranial electrotherapy stimulation
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if firefighters can use a device called cranial electrotherapy stimulation (CES) at home. The trial also wants to see if using CES can help reduce stress in firefighters. The trial

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of cranial electrotherapy stimulation may include dizziness, headache, skin irritation where the electrodes are placed, or discomfort during treatment. However, CES devices like Alpha-Stim AID are generally considered safe with minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 56 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had brain-related health issues like tumors, strokes, seizures, dementia, or brain surgery.
Select...
I need hospital care for my mental health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post four weeks of cranial electrotherapy stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post four weeks of cranial electrotherapy stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions in four weeks
Intensity of anxiety assessed by VAS
Number of completed cranial electrotherapy stimulation sessions in four weeks
Secondary study objectives
Functional resting state connectivity assessed with magnetic resonance imaging connectivity
Intensity of feelings of fatigue assessed by VAS
Severity of symptoms of posttraumatic stress disorder as measured with the PTSD Checklist for DMS 5 (PCL-5)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alpha-Stim AID cranial electrotherapy stimulationExperimental Treatment1 Intervention
Four-week course of noninvasive cranial electrotherapy stimulation.

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER
466 Previous Clinical Trials
699,050 Total Patients Enrolled
Butler HospitalLead Sponsor
131 Previous Clinical Trials
16,488 Total Patients Enrolled
University of Rhode IslandOTHER
56 Previous Clinical Trials
22,351 Total Patients Enrolled
~4 spots leftby Jan 2025
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