BridgeMD
New treatment option for Anxiety
Official title Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
ClinicalTrials.gov ID: NCT07288008
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- Litigating for disability income for a mental disorder outside the VA compensation and pension process
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.