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

Fisher Wallace Laboratories

Status: Completed

Conditions: Anxiety

Treatments: Device: FW-200

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07093736

Pro00053233

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Immediate treatment with FW-200 device

Experimental group

Treatment:

Device: FW-200

Deferred treatment with FW-200

Other group

Description:

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.

Treatment:

Device: FW-200