Veterans' anxiety relief at home: new brain zapping device tested
NCT ID NCT07288008
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a wearable brain stimulation device called tACS for treating anxiety in up to 40 veterans under age 70. The device delivers low-intensity electrical pulses through scalp electrodes and can be used at home after an in-office training session. Over 8 weeks, researchers will measure changes in anxiety, depression, PTSD, sleep, and thinking skills. The goal is to see if this approach is feasible and helpful for easing anxiety symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Birmingham VA
RECRUITINGBirmingham, Alabama, 35210, United States
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