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Device

Alpha-Stim AID cranial electrotherapy stimulation for Adult

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre and post four weeks of cranial electrotherapy stimulation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 56 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during and following four weeks of cranial electrotherapy stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during and following four weeks of cranial electrotherapy stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and during and following four weeks of cranial electrotherapy stimulation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Alpha-Stim AID cranial electrotherapy stimulationExperimental Treatment1 Intervention

Four-week course of noninvasive cranial electrotherapy stimulation.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

456 Previous Clinical Trials

558,296 Total Patients Enrolled

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,398 Total Patients Enrolled

University of Rhode IslandOTHER

52 Previous Clinical Trials

22,171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for potential participants in this medical study limited to individuals over 18 years of age?

"To be considered eligible for this trial, applicants must fall within the age range of 18 to 56. It should be noted that there are currently three clinical trials available specifically for individuals under the age of 18 and thirteen trials designated for patients over the age of 65."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"As per clinicaltrials.gov, the current status of this trial does not involve patient recruitment. The initial posting date was on January 1st, 2024, and it was last updated on January 2nd, 2024. However, there are currently 15 other ongoing clinical trials actively seeking participants at this time."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for involvement in this medical study?

"To be eligible for this clinical trial, individuals must be of legal age and fall within the range of 18 to 56 years old. Approximately 20 participants will have the opportunity to enroll in the study."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"The main objective of this clinical trial is to assess the number of completed cranial electrotherapy stimulation (CES) sessions within a four-week timeframe. Secondary outcomes include measuring the severity of posttraumatic stress disorder symptoms using the PTSD Checklist for DSM-5 (PCL-5), evaluating functional resting state connectivity through magnetic resonance imaging, and assessing intensity of fatigue using a visual analog scale (VAS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203717.