Restoring consciousness with ultrasonic deep brain stimulation during anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy, right-handed adults with BMI under 30 will receive controlled sedation with either propofol or dexmedetomidine while undergoing functional MRI. Low-intensity focused ultrasound pulsation (LIFUP) will be targeted to brain regions including the dorsolateral prefrontal cortex, anterior insula, and central thalamus while multiple fMRI images are acquired. The device has been designated non-significant risk by the FDA, and the protocol focuses on the ultrasonic stimulation and imaging rather than testing the sedative drugs. The study aims to map mental-function-related brain activity across sedation depths and determine whether ultrasonic stimulation changes the timing of return to consciousness.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Zirui Huang — University of Michigan
• Study coordinator: Aaron Ellis
• Email: aaronel@med.umich.edu
• Phone: 734-647-8129

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.