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Completed

NCT Number: NCT05495945

Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

The decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participants will be right-handed adults
  • Body mass index (BMI) less than 30.
  • All subjects will be English speakers.

Exclusion criteria

  • 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,
  • 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.

Treatment and study plan

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 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

Other names: Diprivan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perceptual Criterion Derived From the Signal Detection Theory (SDT)

    Time frame: Up to 90 minutes

    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).

  2. Sensitivity Derived From the Signal Detection Theory (SDT)

    Time frame: Up to 90 minutes

    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).

  3. Grip Force

    Time frame: Up to 90 minutes

    Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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