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

Sanmai Technologies PBC dba Sanmai1 site in 1 country100 target enrollmentApril 29, 2023

ConditionsAnxiety Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: Sanmai Technologies PBC dba Sanmai
Enrollment: 100
Locations: 1
Primary Endpoint: Hamilton Anxiety Rating Inventory
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2023

End Date

April 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanmai Technologies PBC dba Sanmai

Responsible Party

Sponsor

Eligibility Criteria

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