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

Transcranial alternating current stimulation (tACS) in a wearable brain stimulation device that delivers a low intensity, pulsed, alternating current via scalp electrodes. This device is regulated by the Food and Drug Administration (FDA) within the category of cranial electrotherapy stimulation. 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. More research in Veteran populations and additional outcomes, such as neurocognitive and post-traumatic stress disorder (PTSD) symptoms, is warranted. Methods: 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, PTSD, sleep and neurocognitive measures. Participants may have a concurrent diagnosis of major depressive disorder (MDD) and/or PTSD. They may remain on stable doses of existing antidepressants. After baseline assessment, Veterans meeting eligibility criteria will be trained on the use of the 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. Participants will be trained in the use of the tACS and instructed to use it for 20 minutes in the morning and at bedtime (twice daily). Outcomes and self-reported adherence will be measured at 2, 4, 6, and 8 weeks. In addition to anxiety, depression and quality of life outcomes, neurocognitive measures will be collected to investigate a new area of possible improvement in Veterans. Significance: Testing a novel device that has shown preliminary effectiveness and safety in treating anxiety and depression in a Veteran population is important for advancing the care of Veterans.