Mental FunctionNCT07221539
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
A study testing Propofol for fMRI, Dexmedetomidine for fMRI and Dorsolateral prefrontal cortex (DLPFC) pulsation in people with Mental Function, run by University of Michigan at 1 site in United States.
Trial 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 focused ultrasound pulsation (LIFUP) to stimulate specific areas of the brain while undergoing functional Magnetic… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Function
- What is being tested?
- Propofol for fMRI, Dexmedetomidine for fMRI and Dorsolateral prefrontal cortex (DLPFC) pulsation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 30 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Aaron Ellis, 734-647-8129, aaronel@med.umich.edu
Amy McKinney, 734-647-8129, adrongo@med.umich.edu
About this study
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, the investigators 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.
Read the 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 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."
- Conditions
- Mental Function
- Being tested
- Propofol for fMRI, Dexmedetomidine for fMRI, Dorsolateral prefrontal cortex (DLPFC) pulsation, Anterior insular cortex (AIC) pulsation, Central thalamus (CT) pulsation
- Keywords
- Anesthesia, Propofol, Dexmedetomidine, fMRI, ultrasound, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol for fMRIProcedure or surgery
Propofol infusion
Dexmedetomidine for fMRIProcedure or surgery
Dexmedetomidine infusion
Dorsolateral prefrontal cortex (DLPFC) pulsationDevice
BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
Anterior insular cortex (AIC) pulsationDevice
BXPulsar 1002 LIFUP to AIC
Central thalamus (CT) pulsationDevice
BXPulsar 1002 LIFUP to CT
| Study group | Role | What they receive |
|---|---|---|
| Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation | Experimental | Not described Receives: Procedure: Propofol for fMRI; Device: Dorsolateral prefrontal cortex (DLPFC) pulsation |
| Propofol & Anterior insular cortex (AIC) pulsation | Experimental | Not described Receives: Procedure: Propofol for fMRI; Device: Anterior insular cortex (AIC) pulsation |
| Propofol & Central thalamus (CT) pulsation | Experimental | Not described Receives: Procedure: Propofol for fMRI; Device: Central thalamus (CT) pulsation |
| Dexmedetomidine & DLPFC pulsation | Experimental | Not described Receives: Procedure: Dexmedetomidine for fMRI; Device: Dorsolateral prefrontal cortex (DLPFC) pulsation |
| Dexmedetomidine & AIC pulsation | Experimental | Not described Receives: Procedure: Dexmedetomidine for fMRI; Device: Anterior insular cortex (AIC) pulsation |
| Dexmedetomidine & CT pulsation | Experimental | Not described Receives: Procedure: Dexmedetomidine for fMRI; Device: Central thalamus (CT) pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses
Measured: Up to 90 minutes
Secondary outcomes (1)
Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions
Measured: Up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start24 Oct 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FunctionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Zirui Huang, University of Michigan
- Investigators
- Zirui Huang, Principal investigator, University of MichiganAnthony Hudetz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221539
- Sponsor's protocol ID
- HUM00251770
- Other IDs
- R01GM103894
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No