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

Launched by SANMAI TECHNOLOGIES PBC DBA SANMAI · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcranial focused ultrasound (TUS), which is a noninvasive method that uses sound waves to potentially improve mental wellness, behavior, and brain activity in individuals with anxiety disorders. The goal is to see how this brief and gentle treatment affects different aspects of anxiety, like how people feel and think.

To participate, you must be between 18 and 65 years old and able to speak and understand English. It's important that you have been diagnosed with an anxiety disorder in the past year. However, some individuals may not be eligible, such as those with a history of serious head injuries, certain mental health issues, or specific medical conditions like epilepsy or brain tumors. If you join the study, you can expect to undergo some assessments related to your anxiety, and the research team will provide more details about what the process will involve. Remember, this is a chance to help improve treatments for anxiety disorders while being closely monitored for safety.

Gender

ALL

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
• • 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