Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07221539
Status
Recruiting
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Conditions

  • Mental Function

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 24, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation
  • Experimental: Propofol & Anterior insular cortex (AIC) pulsation
  • Experimental: Propofol & Central thalamus (CT) pulsation
  • Experimental: Dexmedetomidine & DLPFC pulsation
  • Experimental: Dexmedetomidine & AIC pulsation
  • Experimental: Dexmedetomidine & CT pulsation

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Aaron Ellis
[email protected]
734-647-8129
Amy McKinney
[email protected]
734-647-8129
Zuiri Huang, Dr. (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI