Transcranial Alternating Current Stimulation for Anxiety

Overseen By Corilyn Ott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Birmingham VA Health Care System

Must be taking: Antidepressants

Must not be taking: Sedatives, Stimulants, Opioids, others

Disqualifiers: Bipolar, Schizophrenia, Severe TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device that uses transcranial alternating current stimulation (tACS) to reduce anxiety. The device is safe, easy to use at home, and may also help those with depression or PTSD. Veterans with moderate anxiety for at least a week, who have not recently undergone certain other treatments, might be suitable for this study. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for anxiety in a flexible and accessible manner.

What prior data suggests that this device is safe for treating anxiety?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe and easy to tolerate. In past studies, both adults and teenagers using tACS reported very few side effects. These studies found that tACS did not cause any serious health issues. Some participants experienced mild sensations like tingling or itching on their scalp where the device was placed. These sensations were temporary and usually subsided quickly.

Additionally, tACS has been tested for home use, indicating it is safe enough to use without constant supervision. This enhances its convenience and safety. Overall, tACS appears to be a safe treatment option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional anxiety treatments that often rely on medications like SSRIs or benzodiazepines, Transcranial Alternating Current Stimulation (tACS) uses a non-invasive electrical approach. Researchers are excited about tACS because it delivers a gentle electrical current to the brain through a wearable device, potentially offering a drug-free alternative with fewer side effects. This method targets brain activity directly, and early indications suggest it might offer faster symptom relief compared to traditional medications.

What evidence suggests that this device is effective for anxiety?

Research has shown that transcranial alternating current stimulation (tACS), which participants in this trial will receive, can help reduce anxiety. One study found that tACS eased anxiety symptoms by improving brain connectivity and calming anxious feelings. Another study found it useful for treating anxiety and related issues like depression. Additionally, tACS improves focus, aiding in anxiety management. Overall, this treatment is generally well-tolerated and works quickly for those dealing with anxiety. ^{1 6 7 8 9}

Who Is on the Research Team?

Lori Davis, MD

Principal Investigator

Birmingham VA Health Care System

Are You a Good Fit for This Trial?

This trial is for veterans under 70 with significant anxiety, who may also have depression or PTSD. It's an open-label study where participants use a tACS device at home after training. The goal is to see if it's feasible and acceptable, and how it affects anxiety, depression, PTSD, sleep, and cognition.

Inclusion Criteria

I speak English and have signed the consent and HIPAA forms.

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

I am 70 years old or younger.

Exclusion Criteria

Dementia or related progressive neurocognitive disorder as per the medical record

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation and Training

Participants receive in-office orientation and training on the use of the tACS device

1 visit

1 visit (in-person)

Treatment

Participants use the tACS device at home for 20 minutes twice daily

8 weeks

4 visits (in-person) at 2, 4, 6, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Alternating Current Stimulation (tACS)

Trial Overview

The trial tests the Model FW-200 tACS device on veterans with anxiety disorders. Over 8 weeks, they'll use this brain stimulation tool at home to assess its impact on mental health conditions like anxiety and PTSD as well as sleep quality and cognitive function.

How Is the Trial Designed?

Group I: Transcranial Alternating Current Stimulation device Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Birmingham VA Health Care System

Lead Sponsor

Trials

4

Recruited

630+

Fisher Wallace Laboratories

Industry Sponsor

Trials

2

Recruited

280+

Citations

1.

nature.com

nature.com/articles/s41380-025-03407-0

a double-blind randomized sham-controlled trial

The transcranial alternating current stimulation (tACS) has been reported to improve attention-related neurophysiological measures in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6277743/

Lasting connectivity increase and anxiety reduction via ...

Critically, this connectivity enhancement was accompanied by sustained reductions in both anxious arousal and negative perception of sensory stimuli. Resting- ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0001691825002525

Effectiveness of transcranial alternating current stimulation ...

This highlights the overall effectiveness of the treatment protocols in influencing outcomes such as anxiety, depression, drug dependence, and VAS scores.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07288008?term=NA

Transcranial Alternating Current Stimulation (tACS) for the ...

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 ...

5.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1419243/full

a systematic review of treatment parameters and outcomes

Regarding neurocognitive disorders, all 13 studies that reported on the efficacy of tACS consistently revealed improvements in the primary or secondary outcomes ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/P230024B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of at-home transcranial direct current ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7867505/

Transcranial alternating current stimulation (tACS): from basic ...

tACS is a unique form of non-invasive brain stimulation. Sinusoidal alternating electric currents are delivered to the scalp to affect mostly cortical neurons.

8.

brainstimjrnl.com

brainstimjrnl.com/article/S1935-861X(24)00974-4/fulltext

Effects of theta transcranial alternating current stimulation ...

The study will provide new insights into the potential of theta-tACS as an easily implementable method to improve the recovery of patients with post-traumatic ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07185451

Efficacy and Safety of Transcranial Alternating Current ...

To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.