AnxietyNCT07288008
Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
A study testing Transcranial alternating current stimulator in people with Anxiety, run by Birmingham VA Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Transcranial alternating current stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Birmingham VA
Birmingham, Alabama, 35210
Kallie Chauncey, 205-933-8101, Kallie.Chauncey@va.gov
Lori Davis, MD
About this study
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.
Read the detailed 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 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.
- Conditions
- Anxiety
- Being tested
- Transcranial alternating current stimulator
- Keywords
- Anxiety, Veterans, Transcranial Alternation Current Stimulation, Post-traumatic stress disorder
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Alternating Current Stimulation device | Experimental | 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. Receives: Device: Transcranial alternating current stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder 7-item (GAD-7)
Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report rated on a 4-point Likert scale of frequency ranging from 0=not at all to 3=nearly every day. Total score ranges from 0 to 21. A total score is interpreted as follows: ≤4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. The GAD-7 is sensitive to detecting a change in anxiety severity over the course of treatment.
Measured: 8 weeks
Secondary outcomes (1)
Patient Health Questionnaire for Depression (PHQ-9)
Patient Health Questionnaire for Depression (PHQ-9) is a 9-item self-report rating scale that assesses symptoms of depression with scores ranging from 0 to 27 (higher score = greater severity of symptoms) measured on 4-point Likert scale from 0=not at all to 3=almost all the days.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Dec 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham VA Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Fisher Wallace Laboratories
- Responsible party
- Principal investigator, Lori L. Davis, Birmingham VA Health Care System
- Investigators
- Lori Davis, MD, Principal investigator, Birmingham VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288008
- Sponsor's protocol ID
- 1893439
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.
PubMed 38696220Lee SH, Kim YK. Application of Transcranial Direct and Alternating Current Stimulation (tDCS and tACS) on Major Depressive Disorder. Adv Exp Med Biol. 2024;1456:129-143. doi: 10.1007/978-981-97-4402-2_7.
PubMed 39261427
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT07288008
- Acronym / sponsor ID
- 1893439
- Conditions
- Anxiety
- Keywords
- Anxiety, Veterans, Transcranial Alternation Current Stimulation, Post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Birmingham VA Health Care SystemUS federal agency
- Collaborators
- Fisher Wallace Laboratories
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Alternating Current Stimulation device | Experimental | Device: Transcranial alternating current stimulatorFisher 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 may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating current stimulatorFisher 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. | Device | Transcranial Alternating Current Stimulation device |
Primary outcome
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: 8 weeks
Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report rated on a 4-point Likert scale of frequency ranging from 0=not at all to 3=nearly every day. Total score ranges from 0 to 21. A total score is interpreted as follows: ≤4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. The GAD-7 is sensitive to detecting a change in anxiety severity over the course of treatment.
1 secondary outcome
Patient Health Questionnaire for Depression (PHQ-9)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 38696220Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.
- Background: PubMed 39261427Lee SH, Kim YK. Application of Transcranial Direct and Alternating Current Stimulation (tDCS and tACS) on Major Depressive Disorder. Adv Exp Med Biol. 2024;1456:129-143. doi: 10.1007/978-981-97-4402-2_7.
- Fisher Wallace web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Davis, MD principal investigator
Birmingham VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulator in people with Anxiety, run by Birmingham VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori L Davis, MD (205-933-8101, lori.davis@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder 7-item (GAD-7) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07288008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.