Status:
RECRUITING
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Mental Function
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 focu...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT07221539
Start Date
October 24 2025
End Date
October 1 2030
Last Update
October 28 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109