Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
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Study type
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Details and patient eligibility
About
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.
Full 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."
Enrollment
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Volunteers
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 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
168 participants in 6 patient groups
Trial contacts and locations
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Central trial contact
Amy McKinney; Aaron Ellis
Data sourced from clinicaltrials.gov
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