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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01GM103894-10A1 | 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. 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.
The decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsolateral prefrontal cortex (DLPFC) | Experimental |
| |
| Anterior insula cortex (AIC) | Experimental |
| |
| Central thalamus (CT) | Experimental |
| |
| Sham control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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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4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation.
1 participant was consented but was a screen fail, so was not randomized.
Participants for this trial were only randomized to the central thalamus arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dorsolateral Prefrontal Cortex (DLPFC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| FG001 | Anterior Insula Cortex (AIC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| FG002 | Central Thalamus (CT) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| FG003 | Sham Control | Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation.
1 participant was consented but was a screen fail, so was not randomized. Participants for this trial were only randomized to the central thalamus arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dorsolateral Prefrontal Cortex (DLPFC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation. 1 participant was consented but was a screen fail, so was not randomized. Participants for this trial were only randomized to the central thalamus arm. | Posted | Mean | Standard Deviation | percentage of BOLD signal | Up to 90 minutes |
|
Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dorsolateral Prefrontal Cortex (DLPFC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zirui Huang | University of Michigan | (734) 615-2875 | huangzu@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2023 | Feb 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2023 | Feb 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Functional Magnetic Resonance Imaging (fMRI) using Propofol | Combination Product | 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 |
|
|
| 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). | Up to 90 minutes |
| Grip Force | Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured. | Up to 90 minutes |
| BG001 | Anterior Insula Cortex (AIC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| BG002 | Central Thalamus (CT) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| BG003 | Sham Control | Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Anterior Insula Cortex (AIC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| OG002 | Central Thalamus (CT) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
| OG003 | Sham Control | Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 |
|
|
|
| Secondary | 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). | 4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation. 1 participant was consented but was a screen fail, so was not randomized. Participants for this trial were only randomized to the central thalamus arm. | Posted | Mean | Standard Deviation | score on a scale | Up to 90 minutes |
|
|
|
|
| Secondary | 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). | 4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation. 1 participant was consented but was a screen fail, so was not randomized. Participants for this trial were only randomized to the central thalamus arm. | Posted | Mean | Standard Deviation | score on a scale | Up to 90 minutes |
|
|
|
|
| Secondary | Grip Force | Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured. | 4 participants were consented but did not receive sedation, as they were used as "dry runs" to test behavioral responses without sedation. 1 participant was consented but was a screen fail, so was not randomized. Participants for this trial were only randomized to the central thalamus arm. | Posted | Mean | Standard Deviation | mmHg | Up to 90 minutes |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Anterior Insula Cortex (AIC) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Central Thalamus (CT) | 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. Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | Sham Control | Functional Magnetic Resonance Imaging (fMRI) using Propofol: 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mild Episode of Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Mild Tenderness at IV site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mild Head Tenderness at Ultrasound Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |