Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
University of Michigan
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.
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."
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
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 scan…
Interventions
- ProcedurePropofol for fMRI
Propofol infusion
- ProcedureDexmedetomidine for fMRI
Dexmedetomidine infusion
- DeviceDorsolateral prefrontal cortex (DLPFC) pulsation
BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
- DeviceAnterior insular cortex (AIC) pulsation
BXPulsar 1002 LIFUP to AIC
- DeviceCentral thalamus (CT) pulsation
BXPulsar 1002 LIFUP to CT
Location
- University of MichiganAnn Arbor, Michigan