tACS for Anxiety Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help individuals with anxiety disorders, such as generalized anxiety disorder, social anxiety, separation anxiety in children, and PTSD. The treatment uses transcranial alternating current stimulation (tACS), a non-invasive technique that gently stimulates the brain to potentially ease anxiety symptoms. Participants will receive either the real tACS treatment or a sham version, with the option to try the actual treatment later. Those with long-standing anxiety disorders that impact daily life may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in anxiety treatment.
Do I need to stop my current medications to join the trial?
The trial requires that your current medications for non-excluded conditions have been stable for at least eight weeks before joining. If your medications are stable, you likely won't need to stop them.
What prior data suggests that transcranial alternating current stimulation (tACS) is safe for treating anxiety disorders?
Research has shown that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated. A study on its use in teenagers found that tACS had few side effects, similar to those in the group that did not receive it, suggesting safety for younger people and, by extension, adults. Another review found that tACS could help treat mental health issues without serious side effects. Although specific data on anxiety patients is limited, these findings suggest tACS is a safe option for trial participants.12345
Why do researchers think this study treatment might be promising for anxiety?
Researchers are excited about transcranial alternating current stimulation (tACS) for anxiety disorders because it offers a non-invasive way to modulate brain activity. Unlike traditional treatments such as medication, which often target neurotransmitters, tACS uses electrical currents to directly influence brainwave patterns. This approach could potentially reduce side effects associated with medications and provide a new option for those who haven't responded well to existing therapies. Additionally, tACS can be tailored to individual brain activity, offering a personalized treatment strategy.
What evidence suggests that transcranial alternating current stimulation (tACS) is effective for anxiety disorders?
Research has shown that transcranial alternating current stimulation (tACS) can help reduce anxiety symptoms. In this trial, participants will divide into two groups: an active group receiving tACS and a sham group receiving a placebo treatment. Studies have found that using tACS at a frequency of 5 Hz on specific brain areas can effectively ease anxiety. This method has shown promise as a quick way to relieve anxiety in early research. It targets brain areas linked to anxiety, aiming to reduce its intensity. While more studies are needed, initial results suggest that tACS could be a helpful tool for people with anxiety disorders.36789
Who Is on the Research Team?
Gerald Tramontano
Principal Investigator
NCI Clinical Research Foundation
Are You a Good Fit for This Trial?
This trial is for individuals aged 5 or older with anxiety disorders like GAD, SAD, PTSD, and separation anxiety. Participants must meet specific diagnostic criteria and be stable on any current medications or psychotherapy. They should have a caregiver if needed and no medical conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 25 minutes of 5 Hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- transcranial alternating current stimulation (tACS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeuroCognitive and Behavioral Institute Clinical Research Foundation
Lead Sponsor