Status:
UNKNOWN
The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology
Lead Sponsor:
Sanmai Technologies PBC dba Sanmai
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
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 TU...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06169631
Start Date
April 29 2023
End Date
April 1 2024
Last Update
December 13 2023
Active Locations (1)
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1
Sanmai Technologies PBC
Sunnyvale, California, United States, 94087