Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
Birmingham VA Health Care System
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.
Description
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…
Eligibility
- Age range
- 19–70 years
- Sex
- All
- Healthy volunteers
- No
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 ps…
Interventions
- DeviceTranscranial 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.
Location
- Birmingham VABirmingham, Alabama