Actively Recruiting
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Led by University of Michigan · Updated on 2025-10-28
168
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults classified as ASA Physical Status 1
- Right-handed adults
- Body mass index (BMI) less than 30
- English speakers
You will not qualify if you...
- Unable to undergo MRI scanning due to medical reasons, possible pregnancy, or current breastfeeding
- Body mass index (BMI) greater than 30
- Presence of metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease
- Structural brain abnormalities seen on MRI scans
- Allergy to propofol, dexmedetomidine, eggs, or soy products
- History of neurological, cardiovascular, or pulmonary illness
- Significant head injury with loss of consciousness
- Learning disability or developmental disorders
- Sleep apnea or severe snoring
- Gastroesophageal reflux disease (GERD) or heartburn
- Pancreatitis or history of pancreatitis
- Sensory or motor loss affecting study participation
- Epilepsy, seizure disorder, or history of stroke
- Tattoos on head or neck; other tattoos assessed for safety
- Recent food or liquid intake within 8 hours
- History of drug use, positive drug screen, unwillingness to abstain from alcohol for 24 hours before dosing, or current nicotine use
- Negative pregnancy test required if applicable
- Participation in another clinical trial with investigational drug or device within past 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Aaron Ellis
CONTACT
A
Amy McKinney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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