Recruiting

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

Sponsor:

Birmingham VA Health Care System

Code:

NCT07288008

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

Interventions

Transcranial alternating current stimulator

Study Details

Brief summary:

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

Anxiety

Study ID

NCT07288008

Start date

Dec 15, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Alternating Current Stimulation device

Fisher Wallace FW-200 Stimulator, a wearable, battery-powered (2 AA) tACS device comprised of a handheld pulse generator, 2 electrodes that attach to the pulse generator via wires, and an adjustable headband used to secure the electrodes. The tACS device delivers 2 mA (±10% tolerance) of pulsed alternating current, with a pulse width of 33.3 microseconds, using a rectangular, bipolar (bidirectional) waveform, employing a 15,000-Hz carrier frequency and 2 modulating frequencies of 500 Hz and 15 Hz, delivered through two 1.5-inch-diameter (circular) sponge electrodes moistened with tap water and secured under the headband at the squamous temporal bone above the posterior aspect of the zygomatic arch on either side of the head (i.e., center of each electrode located, respectively, at EEG coordinates FTT7h and FTT8h) . The device turns off automatically after each 20-minute treatment session.

Interventions

Transcranial alternating current stimulator

Primary outcome measure

Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Lori L Davis, MD

205-933-8101 lori.davis@va.gov

Corilyn Ott, PhD

205-933-8101 corilyn.ott@va.gov

Locations

Birmingham VA

Recruiting

Birmingham, Alabama, United States, 35210

Contacts

Kallie Chauncey

205-933-8101 Kallie.Chauncey@va.gov

Principal Investigator:

Lori Davis, MD

More Information

Sponsor

Birmingham VA Health Care System

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

Anxiety
Veterans
Transcranial Alternation Current Stimulation
Post-traumatic stress disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Birmingham VA Health Care System on 2025-12-31.