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

Not Applicable

Recruiting

• Conditions: Anxiety Disorders

• Registration Number: NCT06169631
• Lead Sponsor: Sanmai Technologies PBC dba Sanmai

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.

Study Timeline

• Study Start: 2023-04-29
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Inventory	1 month	Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety

Trial Locations

Locations (1)

Sanmai Technologies PBC; 🇺🇸 Sunnyvale, California, United States