Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

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.

Conditions

• Mental Function

Interventions

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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Zirui Huang · University of Michigan

• Anthony Hudetz · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-24

Primary Completion

2030-09-30

Completion

2030-10-31

FDA Device

Yes

Countries

• United States

Study Locations