Mental FunctionPhase 2NCT05495945
Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
A Phase 2 study testing Low-intensity focused ultrasound pulsation (LIFUP) and Functional Magnetic Resonance Imaging (fMRI) using Propofol 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. The researchers 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 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?
- Low-intensity focused ultrasound pulsation (LIFUP) and Functional Magnetic Resonance Imaging (fMRI) using Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to 7 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The participants will be right-handed adults
- Body mass index (BMI) less than 30.
- All subjects will be English speakers.
Who cannot join
- Participants will be excluded if they have any medical contraindication to MRI scanning
- Unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
- BMI>30
- Metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease;
- Intracranial structural abnormality on T1-weighted MRI scans.
- Potential subjects will be excluded if they have a history of allergy to propofol, eggs or egg products, soybean or soybean products,
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- Neurological, cardiovascular, or pulmonary illness;
- 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. 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. To eliminate aspiration risk subjects will also be excluded if they have had recent food or liquid intake (within 8 hours). Subjects will be excluded if they have a 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. Women will be required to take a pregnancy test prior to participation to ensure a negative result. The pre-scan drug screen and pregnancy test will be paid for by the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if mental functions take place during different levels of anesthesia. The researchers 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 decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.
- Conditions
- Mental Function
- Being tested
- Low-intensity focused ultrasound pulsation (LIFUP), Functional Magnetic Resonance Imaging (fMRI) using Propofol
- Keywords
- Propofol, Anesthesia, Ultrasound, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasound pulsation (LIFUP)Device
LIFUP will be used to stimulate specific brain regions and assess their causal involvement in the control of conscious state and contents.
Functional Magnetic Resonance Imaging (fMRI) using PropofolCombination product
Also called Diprivan
Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral prefrontal cortex (DLPFC) | Experimental | Not described Receives: Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Anterior insula cortex (AIC) | Experimental | Not described Receives: Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Central thalamus (CT) | Experimental | Not described Receives: Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Sham control | Active comparator | Not described Receives: Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
BOLD signal was measured by Magnetic Resonance Imaging (MRI) scanning of the brain in response to a visual stimuli. This method reflected changes in oxygenation of blood in the brain during a scene-processing task.
Measured: Up to 90 minutes
Secondary outcomes (3)
Perceptual Criterion Derived From the Signal Detection Theory (SDT)
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant's tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).
Measured: Up to 90 minutes
Sensitivity Derived From the Signal Detection Theory (SDT)
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal).
Measured: Up to 90 minutes
Grip Force
Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured.
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 posted10 Aug 2022
- Study start26 Aug 2022
- Primary completion7 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
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 Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495945
- Sponsor's protocol ID
- HUM00213014
- Other IDs
- 2R01GM103894-10A1
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2022
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
- ClinicalTrials.gov ID
- NCT05495945
- Acronym / sponsor ID
- HUM00213014
- Conditions
- Mental Function
- Keywords
- Propofol, Anesthesia, Ultrasound, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if mental functions take place during different levels of anesthesia. The researchers 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.
Detailed description
The decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral prefrontal cortex (DLPFC) | Experimental | Device: Low-intensity focused ultrasound pulsation (LIFUP), Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Anterior insula cortex (AIC) | Experimental | Device: Low-intensity focused ultrasound pulsation (LIFUP), Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Central thalamus (CT) | Experimental | Device: Low-intensity focused ultrasound pulsation (LIFUP), Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
| Sham control | Active comparator | Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participants will be right-handed adults
- Body mass index (BMI) less than 30.
- All subjects will be English speakers.
Key exclusion criteria (11 listed)
- Participants will be excluded if they have any medical contraindication to MRI scanning
- Unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
- BMI>30
- Metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease;
- Intracranial structural abnormality on T1-weighted MRI scans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity focused ultrasound pulsation (LIFUP)LIFUP will be used to stimulate specific brain regions and assess their causal involvement in the control of conscious state and contents. | Device | Anterior insula cortex (AIC), Central thalamus (CT), Dorsolateral prefrontal cortex (DLPFC) |
| Functional Magnetic Resonance Imaging (fMRI) using PropofolAlso: DiprivanPropofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations | Combination product | Anterior insula cortex (AIC), Central thalamus (CT), Dorsolateral prefrontal cortex (DLPFC), Sham control |
Primary outcome
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
Time frame: Up to 90 minutes
BOLD signal was measured by Magnetic Resonance Imaging (MRI) scanning of the brain in response to a visual stimuli. This method reflected changes in oxygenation of blood in the brain during a scene-processing task.
3 secondary outcomes
Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Time frame: Up to 90 minutes
Sensitivity Derived From the Signal Detection Theory (SDT)
Time frame: Up to 90 minutes
Grip Force
Time frame: Up to 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zirui Huang principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-intensity focused ultrasound pulsation (LIFUP) and Functional Magnetic Resonance Imaging (fMRI) using Propofol in people with Mental Function, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli (time frame: Up to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.