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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 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.
Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.
The stimulus set will include real and scrambled images, where the scrambled images will be created by phase-shuffling a randomly chosen real image from each category to preserve category specific low-level image features. Because scrambled images do not include an object stimulus, the images are used as "catch trials" to determine the subjects' baseline tendency to give positive responses to a question about the subjects' recognition experience. Each object category will include four unique real images and one scrambled image. Each image will be repeated 10 times (i.e., trials) for each 16-min session. The pre-stimulus interval will vary randomly from trial to trial between 4 and 8 seconds to prevent stimulus timing predictability. The stimuli will be presented in a randomized order to prevent category predictability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image recognition task | Experimental | The stimulus set will include real and scrambled images, where the scrambled images will be created by phase-shuffling a randomly chosen real image from each category to preserve category specific low-level image features. Each object category will include four unique real images and one scrambled image. Each image will be repeated 10 times (i.e., trials) for each 16-min session. The pre-stimulus interval will vary randomly from trial to trial between 4 and 8 seconds to prevent stimulus timing predictability. The stimuli will be presented in a randomized order to prevent category predictability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) with propofol | Combination Product | Three 16-min sessions in wakeful baseline, light sedation, and recovery will be conducted (Fig. 2). Light sedation will be achieved by IV infusion of propofol to achieve effect-site concentrations of 1.0 μg/ml. Infusion rate will be manually controlled. An initial bolus dose (525 µg/kg) and subsequent infusion rate (82 µg/kg/min) for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Oxygen Level Dependent (BOLD) response to visual stimuli | Visual stimuli evoked activity was quantified by measurements of the fMRI BOLD signal. Neural response to a natural visual stimulus will be assessed during both conscious and anesthetized states. | Up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Perceptual criterion (c) derived from the Signal Detection Theory (SDT) | Up to 90 minutes | |
| Sensitivity (d') criterion derived from the Signal Detection Theory (SDT) | Up to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zirui Huang | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2025 | Nov 11, 2025 | ICF_001.pdf |
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