NCT06169631

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

The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sanmai Technologies PBC dba Sanmai · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DEVICE	Gen0b	The ultrasound will be administered to the brain region of interest.

Timeline

• Start date: 2023-04-29
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-12-13
• Last updated: 2023-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study