Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Function
• Intervention / Treatment: Procedure: Propofol for fMRI; Device: Dorsolateral prefrontal cortex (DLPFC) pulsation; Device: Central thalamus (CT) pulsation; Procedure: Dexmedetomidine for fMRI; Device: Anterior insular cortex (AIC) pulsation

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."

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy McKinney; Phone Number: 734-647-8129; Email: adrongo@med.umich.edu
• Study Contact Backup: Name: Aaron Ellis; Phone Number: 734-647-8129; Email: aaronel@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Amy McKinney; Phone Number: 734-647-8129; Email: adrongo@med.umich.edu
      • Contact: Aaron Ellis; Phone Number: 734-647-8129; Email: aaronel@med.umich.edu
      • Principal Investigator: Zuiri Huang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy study participants with American Society of Anesthesiologists (ASA) Physical Status Classification System-1 status
• The participants will be right-handed adults
• Body mass index (BMI) less than 30.
• All subjects will be English speakers.

Exclusion Criteria:

• Medical contraindication to MRI scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
• BMI>30,
• metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans.
• History of allergy to propofol, dexmedetomidine, any components of propofol or dexmedetomidine, eggs or egg products, soybean or soybean products,
• Neurological, cardiovascular, or pulmonary illness;
• Significant head injury with loss of consciousness;
• Learning disability or other developmental disorder; sleep apnea or any severe snoring history; gastroesophageal reflux disease (GERD) or heartburn; pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study; epilepsy/seizure disorder (including a history of seizures) or stroke (including a history of stroke).
• Participants with tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety.
• Recent food or liquid intake (within 8 hours).
• History of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use. -----Negative pregnancy test result, if applicable.
• Potential participants who have participated in a clinical trial using an investigational drug or device within 30 days will be considered for enrollment after 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation	Procedure: Propofol for fMRI; Propofol infusion; Device: Dorsolateral prefrontal cortex (DLPFC) pulsation; BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
Experimental: Propofol & Anterior insular cortex (AIC) pulsation
Experimental: Propofol & Central thalamus (CT) pulsation	Procedure: Propofol for fMRI; Propofol infusion; Device: Central thalamus (CT) pulsation; BXPulsar 1002 LIFUP to CT
Experimental: Dexmedetomidine & DLPFC pulsation	Device: Dorsolateral prefrontal cortex (DLPFC) pulsation; BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC; Procedure: Dexmedetomidine for fMRI; Dexmedetomidine infusion
Experimental: Dexmedetomidine & AIC pulsation	Procedure: Dexmedetomidine for fMRI; Dexmedetomidine infusion; Device: Anterior insular cortex (AIC) pulsation; BXPulsar 1002 LIFUP to AIC
Experimental: Dexmedetomidine & CT pulsation	Device: Central thalamus (CT) pulsation; BXPulsar 1002 LIFUP to CT; Procedure: Dexmedetomidine for fMRI; Dexmedetomidine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses	Up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions	Up to 90 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Zirui Huang, University of Michigan; Principal Investigator: Anthony Hudetz, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 24, 2025
• First Posted (Estimated): October 28, 2025

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; Healthy Volunteers; fMRI; Propofol; Dexmedetomidine; Anesthesia
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Phenols; Benzene Derivatives; Dexmedetomidine; Propofol
• Other Study ID Numbers: HUM00251770; R01GM103894 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes