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Completed

NCT Number: NCT07093736

A Study Comparing Immediate Treatment to Deferred Treatment With the Fisher Wallace (FW) Stimulator FW-200 Device for the Treatment of Self-reported Anxiety in First Responders

The goal of this clinical trial is to learn if the Fisher Wallace Stimulator FW-200 experimental device is effective at treating self-reported anxiety in first responders. The main question the trial aims to answer is does the FW-200 device improve anxiety as measured by a validated questionnaire.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florence Healthcare, Atlanta, Georgia, United States

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About this study

This is a randomized waitlist-controlled trial to evaluate the efficacy and safety of the Fisher Wallace Stimulator FW-200 device in the treatment of self-reported anxiety in police personnel and first responders. Participants will be randomly assigned to receive immediate treatment or deferred treatment with the FW-200 device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older
  • Ability to read and write in English
  • First responder employee or employee of participating police department
  • Beck Anxiety Inventory total score above 7
  • Able to commit to two 20-minute device treatment session per day for up to 8 weeks
  • Willing to wear an actigraphy device

Exclusion criteria

  • Use of brain stimulation device in the last year
  • Have a pacemaker, electronic stent or electronic implants
  • Started or planning to start new medial treatment or health program over the next 8 weeks
  • Contemplated suicide in the past year
  • Institutionalized for mental health issues
  • Have a serious medical condition
  • Currently taking medications affecting the nervous system
  • Allergic to nickel
  • Currently taking or planning to take part in any other study on insomnia, anxiety or other mental health effort over the next 8 weeks
  • Currently pregnant or planning to become pregnant in the next 10 weeks

Treatment and study plan

FW-200

Device

Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation

Primary outcomes

  1. Beck Anxiety Inventory (BAI) scores

    Time frame: From baseline to week 2

    Change in Beck Anxiety Inventory (BAI) scores at Week 2 versus baseline in immediate treatment group compared to the deferred treatment group. Total score range is a minimum of 0 to a maximum of 63. Higher score means a worse severity of anxiety.

Secondary outcomes

  1. Patient Health Questionnaire

    Time frame: From baseline to week 2 and week 4. Total scores range from 0 to 24. Higher scores mean worse severity of depressive symptoms.

    Change in Patient Health Questionnaire-8

  2. Professional Quality of Life

    Time frame: From baseline to week 2 and week 4

    Change in Professional Quality of Life

  3. Consenting to Study Continuation

    Time frame: Week 4

    Percentage of participants consenting to study continuation at week 4 in the immediate treatment group compared to deferred treatment group

  4. Total Sleep Time

    Time frame: Baseline to through study completion

    Percentage of participants with a 20 minute or more increase in total sleep time for the immediate treatment group compared to the deferred treatment group.

Sponsors and collaborators

Lead sponsor

Fisher Wallace Laboratories

Industry

Collaborators

  • Advarra
  • Florence Healthcare

Registry information

Official study title

A Randomized Waitlist-controlled Trial to Evaluate of the Effectiveness of Immediate Treatment Compared to Deferred Treatment With the Fisher Wallace Stimulator FW-200 Device in First Responders With Self-reported Anxiety

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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