Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
2 other identifiers
interventional
168
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
October 28, 2025
October 1, 2025
4.9 years
October 24, 2025
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses
Up to 90 minutes
Secondary Outcomes (1)
Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions
Up to 90 minutes
Study Arms (6)
Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation
EXPERIMENTALPropofol & Anterior insular cortex (AIC) pulsation
EXPERIMENTALPropofol & Central thalamus (CT) pulsation
EXPERIMENTALDexmedetomidine & DLPFC pulsation
EXPERIMENTALDexmedetomidine & AIC pulsation
EXPERIMENTALDexmedetomidine & CT pulsation
EXPERIMENTALInterventions
Propofol infusion
Dexmedetomidine infusion
BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
BXPulsar 1002 LIFUP to AIC
BXPulsar 1002 LIFUP to CT
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zirui Huang
University of Michigan
- PRINCIPAL INVESTIGATOR
Anthony Hudetz
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor of Anesthesiology and Co-Director, Center for Consciousness Science
Study Record Dates
First Submitted
October 24, 2025
First Posted
October 28, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share