AnxietyNCT07093736
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
A study testing FW-200 in people with Anxiety, run by Fisher Wallace Laboratories at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- FW-200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2021to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Florence Healthcare
Atlanta, Georgia, 30308
Seattle Police Department Wellness Unit
Seattle, Washington, 98104
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Anxiety
- Being tested
- FW-200
- Keywords
- self-reported anxiety, first responder
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FW-200Device
Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment with FW-200 device | Experimental | Not described Receives: 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. Receives: Device: FW-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 2
Secondary outcomes (4)
Patient Health Questionnaire
Change in Patient Health Questionnaire-8
Measured: 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
Change in Professional Quality of Life
Measured: From baseline to week 2 and week 4
Consenting to Study Continuation
Percentage of participants consenting to study continuation at week 4 in the immediate treatment group compared to deferred treatment group
Measured: Week 4
Total Sleep Time
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.
Measured: Baseline to through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start6 Jul 2021
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher Wallace Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advarra, Florence Healthcare
- Responsible party
- Principal investigator, Lois James, Ph.D., Fisher Wallace Laboratories
- Investigators
- Lois James, Ph.D., Principal investigator, James Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093736
- Sponsor's protocol ID
- Pro00053233
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07093736
- Acronym / sponsor ID
- Pro00053233
- Conditions
- Anxiety
- Keywords
- self-reported anxiety, first responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fisher Wallace LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Advarra, Florence Healthcare
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment with FW-200 device | Experimental | Device: FW-200 |
| Deferred treatment with FW-200 | Other | Device: FW-200FW-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FW-200Non-invasive, home-use neurostimulation device delivering transcranial fixed output, alternating current stimulation | Device | Deferred treatment with FW-200, Immediate treatment with FW-200 device |
Primary outcome
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.
4 secondary outcomes
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.
Professional Quality of Life
Time frame: From baseline to week 2 and week 4
Consenting to Study Continuation
Time frame: Week 4
Total Sleep Time
Time frame: Baseline to through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois James, Ph.D. principal investigator
James Consulting
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FW-200 in people with Anxiety, run by Fisher Wallace Laboratories at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) scores (time frame: From baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.