NCT05895474

Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

Safety Assessment of Central Medial Thalamus Stimulation Using Attune ATTN201 Transcranial Focused Ultrasound Stimulator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purposes of this research study are to investigate closed-loop and personalized focused ultrasound as a technique to study how the brain works and to evaluate the safety and effectiveness of the Attune ATTN201 device. This study will objectively assess brain parenchyma morphology, and neuropsychiatric and neuropsychological function, following Transcranial Focused Ultrasound (tFUS) exposure. Electroencephalographic recordings during parametric sweeps will be obtained for observation of changes in the brain network activity, primarily focused on the Central Medial Thalamus (CMT). The CMT maintains strong network connectivity to the cortex and plays a potent role in sleep induction. tFUS has recently emerged as a powerful tool for targeted deep brain neuromodulation and has, in theory, the ability to modulate the activity of the CMT without affecting overlying tissue.

Detailed description

This research study will examine the safety and tolerability of the novel, wearable device Attune ATTN201. This device uses transcranial focused ultrasound (tFUS), a form of noninvasive brain stimulation that uses sound waves to excite or inhibit the brain. The investigators research questions seek to answer how using brain imaging can guide the use of tFUS to stimulate a specific target unique to the participant's brain. This target, the Thalamus, is involved in everyday brain processing and activity. Using the participant's specific brain anatomy and tFUS, the investigators can precisely target this structure and further understand its role in the various functions. Unlike existing technologies, this device will incorporate offline usage, allowing users to comfortably wear the device out of the clinic or research setting for the first time. The unique offline guidance approach uses the participant's head shape and brain anatomy to allow for customizable and repeatable ultrasound delivery to exact, preprogrammed targets. This device will be tested over the course of 1 month per participant, and will offer insights into preparing a larger clinical trial for tFUS use.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Transcranial Focused Ultrasound	Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2023-06-08
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study