Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

Mental Function

Anesthesia, Propofol, Dexmedetomidine, fMRI, ultrasound, Healthy Volunteers

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.

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.

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