Restoring consciousness with ultrasonic deep brain stimulation during anesthesia
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
We will try low-intensity focused ultrasound during MRI in healthy adults sedated with propofol or dexmedetomidine to see if it speeds return of consciousness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07221539 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy, English-speaking, right-handed adults with ASA physical status I and BMI below 30 who can safely undergo MRI and receive standard sedative medications.
Not a fit: People with neurological, cardiovascular, or pulmonary illness, significant head injury, BMI over 30, pregnancy or breastfeeding, MRI contraindications, or allergies to the study drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could shorten or accelerate recovery of consciousness after sedation and inform new treatments for disorders of consciousness.
How similar studies have performed: Early animal and small human studies show ultrasound can modulate brain activity, but using focused ultrasound to restore consciousness during anesthesia is largely novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.