NCT07221539

Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if mental functions take place during different levels of anesthesia using two commonly used drug (propofol and dexmedetomidine) and will include low-intensity focused ultrasound pulsation (LIFUP) to stimulate specific areas of the brain while undergoing functional Magnetic Resonance Imaging (fMRI or "brain imaging"), which shows areas in the brain involved in thinking at different depths of anesthesia. That is, ultrasound is being used to stimulate the brain and multiple pictures will be taken of the brain. As a result of this study, we expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.

Detailed description

The FDA determined this trial is a non-significant risk (NSR) device study. Although Propofol and Dexmedetomidine, which are FDA-approved drugs for use in patients undergoing an anesthetic for medical treatment, will be used in this trial, the FDA determined that the trial will not be studying these drugs. Rather, the FDA determined this trial will be studying the NSR device. To ensure consistency with the FDA's determination, the field for "U.S. FDA-regulated Drug" in this record has been marked as "No."

Conditions

• Mental Function

Interventions

Type	Name	Description
PROCEDURE	Propofol for fMRI	Propofol infusion
PROCEDURE	Dexmedetomidine for fMRI	Dexmedetomidine infusion
DEVICE	Dorsolateral prefrontal cortex (DLPFC) pulsation	BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
DEVICE	Anterior insular cortex (AIC) pulsation	BXPulsar 1002 LIFUP to AIC
DEVICE	Central thalamus (CT) pulsation	BXPulsar 1002 LIFUP to CT

Timeline

• Start date: 2025-10-24
• Primary completion: 2030-09-01
• Completion: 2030-10-01
• First posted: 2025-10-28
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study