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

NCT07288008 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fisher Wallace Laboratories

    collaborator INDUSTRY

  • Birmingham VA Health Care System

    lead FED

Principal Investigators

  • Lori Davis, MD · Birmingham VA Health Care System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288008 on ClinicalTrials.gov