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

Status unconfirmed · Not applicable

Conditions studied: Anxiety Disorders

In brief

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.

Key facts

Study ID

NCT06169631

Run by

Sanmai Technologies PBC dba Sanmai

People needed

100

Starts

2023-04-29

Expected to finish

2024-04-01

Last updated by the study team

2023-12-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sanmai Technologies PBC — Sunnyvale, California, United States (enrolling)

Full record on ClinicalTrials.gov

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