Actively Recruiting
Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
Led by Birmingham VA Health Care System · Updated on 2025-12-31
40
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
B
Birmingham VA Health Care System
Lead Sponsor
F
Fisher Wallace Laboratories
Collaborating Sponsor
AI-Summary
What this Trial Is About
Transcranial alternating current stimulation (tACS) in a wearable brain stimulation device that delivers a low intensity, pulsed, alternating current via scalp electrodes. Prior sham-controlled clinical trials have shown the therapeutic effects and safety of tACS for the treatment of anxiety and depression. In addition, tACS is rapid acting and well tolerated. After the device is issued to the patient during an in-office orientation and training session, the tACS device can be safely used by the patient at the convenience of their own home. Up to 40 Veterans under that age of 70 who have clinically significant anxiety will be enrolled in an 8-week open-label trial of Model FW-200 tACS to evaluate feasibility, acceptability, adherence and impact on anxiety, depression, post-traumatic stress disorder (PTSD), sleep and neurocognitive measures. Participants may have a concurrent diagnosis of major depressive disorder (MDD) and/or PTSD.
CONDITIONS
Official Title
Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran of the U.S. military
- English-speaking and provides signed informed consent and HIPAA
- Adults 470 years of age
- Past week's GAD-7 of �b510 indicating at least moderate anxiety
- Stable antidepressant use for �b58 weeks and stable doses for �b54 weeks if applicable
- Negative pregnancy test and agreement to medically accepted birth control for participants of child-bearing potential
You will not qualify if you...
- History of bipolar type I, schizophrenia spectrum, or other psychotic disorders
- Current sedative-hypnotic, stimulant, inhalant, or opioid use disorder within past 6 months
- Moderate to severe alcohol or cannabis use disorder within past 6 months
- History of severe traumatic brain injury
- Diagnosis of dementia or related progressive neurocognitive disorder
- Use of prohibited medications in prior 2 weeks
- Increased suicide risk requiring inpatient treatment or recent suicidal behaviors
- Electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation within past 6 months
- Implanted central nervous system devices or cardiac pacemaker
- Current symptomatic trigeminal neuralgia
- Recent evidence-based psychotherapy for anxiety, depression, or PTSD within past 14 days
- Pregnancy during treatment
- Significant medical or surgical illness contraindicating tACS use
- Litigating for disability income for mental disorder outside VA process
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Birmingham VA
Birmingham, Alabama, United States, 35210
Actively Recruiting
Research Team
L
Lori L Davis, MD
CONTACT
C
Corilyn Ott, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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