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RECRUITING

NCT07288008

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

Sponsor: Birmingham VA Health Care System

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-15

Completion Date

2028-06-30

Last Updated

2025-12-31

Healthy Volunteers

Conditions

Anxiety

Interventions

DEVICE

Transcranial alternating current stimulator

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.

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

Locations (1)

Birmingham VA

Birmingham, Alabama, United States