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

NCT07093736 | Completed FDA Device

• 1 other identifier: Pro00053233
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety

Keywords

self-reported anxiety; first responder

Outcome Measures

Primary Outcomes (1)

• Beck Anxiety Inventory (BAI) scores

  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.

  From baseline to week 2

Secondary Outcomes (4)

• Patient Health Questionnaire

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

• Professional Quality of Life

  From baseline to week 2 and week 4

• Consenting to Study Continuation

  Week 4

• Total Sleep Time

  Baseline to through study completion

Study Arms (2)

Immediate treatment with FW-200 device

EXPERIMENTAL

Device: FW-200

Deferred treatment with FW-200

OTHER

FW-200 treatment was delayed for two-weeks to measure the natural progression of anxiety symptoms over a short period without intervention and to establish a baseline for how rapidly symptoms may escalate or impair functioning.

Device: FW-200

Interventions

FW-200 DEVICE

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

Deferred treatment with FW-200; Immediate treatment with FW-200 device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher Wallace Laboratories: lead
• Advarra: collaborator
• Florence Healthcare: collaborator

Study Sites (2)

Florence Healthcare

Atlanta, Georgia, 30308, United States

Location

Seattle Police Department Wellness Unit

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Lois James, Ph.D.

  James Consulting

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, WSU College of Nursing

Model Details: This study was a waitlist-controlled study where the subjects were randomly assigned to receive an intervention immediately or after a specified delay. The two-week delay was designed to measure the natural progression of anxiety symptoms over a short period without intervention and to establish a baseline for how rapidly symptoms may escalate or impair functioning.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 30, 2025
• Study Start: July 6, 2021
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (2)