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

Sanmai Technologies

Status: Enrolling

Conditions: Anxiety Disorders

Treatments: Device: Gen0b

Study type: Interventional

Funder types: Industry

Identifiers

NCT06169631

Pro00064110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Experiment 1

Experimental group

Description:

The study will consist of 2 groups. A: no current diagnosis of anxiety or other psychological disorders. B: Current diagnosis of anxiety disorder. Results will be analyzed within and between groups. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions.

Treatment:

Device: Gen0b

Experiment 2a

Experimental group

Description:

Current diagnosis of anxiety disorder is required. Participants will receive an MRI. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions

Treatment:

Device: Gen0b

Experiment 2b

Experimental group

Description:

Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a.

Treatment:

Device: Gen0b