Transcranial Alternating Current Stimulation (tACS) for Anxiety in Veterans

This study is looking at how well a wearable device called the Fisher Wallace FW-200 Stimulator helps reduce anxiety in U.S. military Veterans. This device delivers a gentle electrical current to the scalp. We are looking for up to 40 Veterans, aged 19 to 70, who have at least a moderate level of anxiety. You can continue taking your current antidepressants if you've been on them for a stable period. The main goal is to see if your anxiety, measured by a common questionnaire (GAD-7), improves after 8 weeks of using the device at home. This study also checks how easy the device is to use and if people stick with the treatment.

Study design
This is an open-label pilot study, meaning everyone receives the treatment and there's no comparison group. Up to 40 participants will be enrolled.
What's involved
You will have an in-office orientation and training session to learn how to use the tACS device. After that, you will use the device safely at home for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety will be measured at 8 weeks.

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NCT07288008

Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study

Recruiting
NAAges 19–70InterventionalTreatment
Birmingham VA Health Care System
~40 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Transcranial alternating current stimulator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Generalized Anxiety Disorder 7-item (GAD-7)
Measured over 8 weeks
Anxiety
1 sites across 1 states
Alabama1
  • Lori Davis, MD · PRINCIPAL_INVESTIGATOR · Birmingham VA Health Care System

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Veteran of the U.S. military
English-speaking and provides signed informed consent and HIPAA
Adults ≤70 years of age
Past week's GAD-7 of ≥10 which represents at least moderate level of anxiety
If applicable, antidepressants may be continued if taking the concomitant medication for ≥8 weeks and at stable doses for ≥4 weeks
Participants of child-bearing potential must have negative pregnancy test at entry and must agree to adhere to a medically acceptable method of birth control

Exclusion

Lifetime bipolar type I, schizophrenia spectrum, or other psychotic disorders based on VA medical records
Current sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within the past 6 months based on VA medical records and clinical interview
Diagnosis of moderate to severe alcohol and/or cannabis use disorder within past 6 months based on VA medical records and clinical interview
History of severe traumatic brain injury (TBI), defined by Ohio State University TBI Identification Method
Dementia or related progressive neurocognitive disorder as per the medical record
Use of prohibited medications (see list above) in the prior 2 weeks
Increased risk of suicide that necessitates inpatient treatment, suicidal ideation/behavior endorsed on 6-item Columbia Suicide Severity Rating Scale screening questionnaire (yes" to question 4 or 5; or yes to # 6 as current), and/or suicidal behavior within past 90 days.
Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation within the past 6 months
Implanted central nervous system devices (e.g. deep brain stimulation)
Implanted cardiac pacemaker
Trigeminal neuralgia that is currently symptomatic
Treatment with evidence-based psychotherapy (EBP) for anxiety, depression or PTSD in the past 14 days. If receiving EBP therapy, he/she should complete EBP prior to entering study. Veterans currently engaged in non-EBP, e.g., supportive counseling or skills group therapies, may continue in these if they have been in this treatment for at least 4 weeks prior to baseline assessments.
Pregnancy during treatment
Clinically significant medical/surgical illness that would contraindicate use of tACS, e.g. unstable cardiac condition, those who fear electrical stimulation, presence of skin irritation or abrasions around either electrode site, or who have shrapnel fragments near either electrode site.
Litigating for disability income for a mental disorder outside the VA compensation and pension process
  • Generalized Anxiety Disorder 7-item (GAD-7)8 weeks

    Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report rated on a 4-point Likert scale of frequency ranging from 0=not at all to 3=nearly every day. Total score ranges from 0 to 21. A total score is interpreted as follows: ≤4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. The GAD-7 is sensitive to detecting a change in anxiety severity over the course of treatment.