tACS for Anxiety Disorders

Phase 2

Recruiting

Led By Gerald Tramontano

Research Sponsored by NeuroCognitive and Behavioral Institute Clinical Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable medications for non-excluded concurrent medical conditions for eight weeks prior to randomization

Age range: 5 years of age or older

Must not have

Raised intracranial pressure

Schizophrenia spectrum disorders and bipolar spectrum disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

Summary

This trial explores using a non-invasive intervention to treat anxiety disorders such as GAD, SAD, PTSD, and childhood separation anxiety. Participants are randomly assigned to receive a 25-minute 5 hz tACS or sham, with an optional extension phase.

Who is the study for?

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.

What is being tested?

The trial tests transcranial alternating current stimulation (tACS) at 5 hz up to 2mA targeting the brain's amygdala over 12 sessions within a month. It aims to see if tACS can reduce anxiety symptoms compared to sham (placebo-like) treatment, followed by an optional phase where everyone receives tACS.

What are the potential side effects?

Potential side effects of tACS may include discomfort at the electrode sites, mild headaches, dizziness or nausea during or after treatment. These are usually temporary and resolve soon after each session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medications for other health conditions have been stable for 8 weeks.

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I am 5 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have increased pressure in my brain.

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I have been diagnosed with schizophrenia or bipolar disorder.

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I have a neurodegenerative disease.

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I have epilepsy.

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I have a rounded skull defect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks. for reporting.