Trial Outcomes & Findings for Ultrasonic Deep Brain Stimulation During Anesthetic Sedation (NCT NCT05495945)
NCT ID: NCT05495945
Last Updated: 2025-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 90 minutes
Results posted on
2025-03-12
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
8
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Baseline characteristics by cohort
| Measure |
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
|
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
|
Central Thalamus (CT)
n=8 Participants
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
|
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
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
—
|
25.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
—
|
25.1 years
STANDARD_DEVIATION 6.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 90 minutesPopulation: 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.
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.
Outcome measures
| Measure |
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
|
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
|
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
|
Central Thalamus (CT)
n=8 Participants
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
|
|---|---|---|---|---|
|
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
Baseline
|
—
|
—
|
—
|
0.56 percentage of BOLD signal
Standard Deviation 0.03
|
|
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
Following Intervention
|
—
|
—
|
—
|
0.51 percentage of BOLD signal
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Up to 90 minutesPopulation: 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.
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).
Outcome measures
| Measure |
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
|
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
|
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
|
Central Thalamus (CT)
n=8 Participants
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
|
|---|---|---|---|---|
|
Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Baseline
|
—
|
—
|
—
|
0.56 score on a scale
Standard Deviation 0.89
|
|
Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Following Intervention
|
—
|
—
|
—
|
0.80 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Up to 90 minutesPopulation: 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.
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).
Outcome measures
| Measure |
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
|
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
|
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
|
Central Thalamus (CT)
n=8 Participants
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
|
|---|---|---|---|---|
|
Sensitivity Derived From the Signal Detection Theory (SDT)
Baseline
|
—
|
—
|
—
|
0.72 score on a scale
Standard Deviation 0.50
|
|
Sensitivity Derived From the Signal Detection Theory (SDT)
Following Intervention
|
—
|
—
|
—
|
0.39 score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Up to 90 minutesPopulation: 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.
Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured.
Outcome measures
| Measure |
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
|
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
|
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
|
Central Thalamus (CT)
n=8 Participants
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
|
|---|---|---|---|---|
|
Grip Force
Baseline
|
—
|
—
|
—
|
13.8 mmHg
Standard Deviation 5.3
|
|
Grip Force
Following Intervention
|
—
|
—
|
—
|
11.9 mmHg
Standard Deviation 3.8
|
Adverse Events
Dorsolateral Prefrontal Cortex (DLPFC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anterior Insula Cortex (AIC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Central Thalamus (CT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
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
|
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
|
Central Thalamus (CT)
n=8 participants at risk
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
|
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
|
|---|---|---|---|---|
|
General disorders
Moderate Fatigue
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
12.5%
1/8 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
|
Respiratory, thoracic and mediastinal disorders
Mild Episode of Apnea
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
12.5%
1/8 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
|
Skin and subcutaneous tissue disorders
Mild Tenderness at IV site
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
12.5%
1/8 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
|
Skin and subcutaneous tissue disorders
Mild Head Tenderness at Ultrasound Site
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
12.5%
1/8 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
—
0/0 • Up to 24 hours
Participants were only randomized to the Central Thalamus arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place