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| ID | Type | Description | Link |
|---|---|---|---|
| R01GM103894 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation | Experimental |
| |
| Propofol & Anterior insular cortex (AIC) pulsation | Experimental | ||
| Propofol & Central thalamus (CT) pulsation | Experimental |
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| Dexmedetomidine & DLPFC pulsation | Experimental |
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| Dexmedetomidine & AIC pulsation | Experimental |
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| Dexmedetomidine & CT pulsation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol for fMRI | Procedure | Propofol infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses | Up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions | Up to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron Ellis | Contact | 734-647-8129 | aaronel@med.umich.edu | |
| Amy McKinney | Contact | 734-647-8129 | adrongo@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zirui Huang | University of Michigan | Principal Investigator |
| Anthony Hudetz | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Dexmedetomidine for fMRI | Procedure | Dexmedetomidine infusion |
|
| Dorsolateral prefrontal cortex (DLPFC) pulsation | Device | BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC |
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| Anterior insular cortex (AIC) pulsation | Device | BXPulsar 1002 LIFUP to AIC |
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| Central thalamus (CT) pulsation | Device | BXPulsar 1002 LIFUP to CT |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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