Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Primary completion moved earlier from Sep 2030 to Jul 30, 2027
    • Study completion moved earlier from Oct 2030 to Jul 30, 2027
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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, the investigators 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 Details
NCT Number NCT07221539
Lead Sponsor University of Michigan
Collaborators: National Institute of General Medical Sciences (NIGMS)
Conditions
(from sponsor)		 Mental Function
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov