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

Last updated: December 12, 2023
Sponsor: Sanmai Technologies PBC dba Sanmai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Anxiety Disorders

Panic Disorders

Treatment

Gen0b

Clinical Study ID

NCT06169631
Pro00064110
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 theconsent form.
  • Experiment 2 : Participants will be included for a past diagnosis of anxiety withinthe past year.

Exclusion

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 withtesting, including drug and/or alcohol dependence
  • History of epilepsy
  • Brain tumors
  • Takes medications or drugs judged likely to change brain activity, includingpsychoactive 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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Gen0b
Phase:
Study Start date:
April 29, 2023
Estimated Completion Date:
April 30, 2024

Study 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.

Connect with a study center

  • Sanmai Technologies PBC

    Sunnyvale, California 94087
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.