The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology

Study Overview
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Brief Summary
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The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.

Detailed Description
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We will test the effects of TUS on self-reported and clinical anxiety states in healthy participants and in those with diagnosed anxiety disorders. Participants in these studies will receive pulsed TUS to the brain regions of interest. We will test whether multiple doses of TUS lead to larger reductions in mental states related to anxiety in comparison to a single dose of TUS.

Official Title
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The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Device: Gen0b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age, as verified via photo identification with date of birth. Should be an English speaker, as indicated by being able to read and comprehend the consent form. Experiment 2 : Participants will be included for a past diagnosis of anxiety within the past year. Exclusion Criteria: Smokes or uses tobacco products or any form of nicotine excessively History of head injury with loss of consciousness for more than 5 min Uncorrected hearing or vision impairment, including color blindness Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence History of epilepsy Brain tumors Takes medications or drugs judged likely to change brain activity, including psychoactive drugs, stimulants, benzodiazepines, and/or others Factors that may lead to poor EEG or fNIRS recordings (e.g., hairstyle) Inadequate sleep Drug, alcohol or prescription drug intoxication, dependence or addiction Pregnancy, or becoming pregnant during the course of the study Mild cognitive impairment or impaired decision making History of migraines Experience with neurostimulation (which might unbind or alter the results) Metal implants in their head or face

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each experiment arm will have its own group(s).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment 1<br>The study will consist of 2 groups. A: no current diagnosis of anxiety or other psychological disorders. B: Current diagnosis of anxiety disorder. Results will be analyzed within and between groups. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions. | Device: Gen0b<br>* The ultrasound will be administered to the brain region of interest.<br>|
| Experimental: Experiment 2a<br>Current diagnosis of anxiety disorder is required. Participants will receive an MRI. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions | Device: Gen0b<br>* The ultrasound will be administered to the brain region of interest.<br>|
| Experimental: Experiment 2b<br>Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a. | Device: Gen0b<br>* The ultrasound will be administered to the brain region of interest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Inventory | Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety | 1 month |