NCT06426498

tFUS Induced Transient Scotoma for Individual Dosing

Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purposes of this research study is to: 1. Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured. 2. Use this technique to measure threshold for effective tFUS in individuals. 3. Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS.

Detailed description

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Brainsonix Bx Pulsar machine tFUS	This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines.

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-05-20
• Completion: 2026-08-20
• First posted: 2024-05-23
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study