Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

NCT ID: NCT05495945

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2023-10-07

Brief Summary

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.

Detailed Description

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

Conditions

Mental Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dorsolateral prefrontal cortex (DLPFC)

Group Type: EXPERIMENTAL

Low-intensity focused ultrasound pulsation (LIFUP)

Intervention Type: 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

Intervention Type: 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

Anterior insula cortex (AIC)

Group Type: EXPERIMENTAL

Low-intensity focused ultrasound pulsation (LIFUP)

Intervention Type: 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

Intervention Type: 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

Central thalamus (CT)

Group Type: EXPERIMENTAL

Low-intensity focused ultrasound pulsation (LIFUP)

Intervention Type: 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

Intervention Type: 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

Sham control

Group Type: ACTIVE_COMPARATOR

Functional Magnetic Resonance Imaging (fMRI) using Propofol

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Diprivan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Zirui Huang

Research Assistant Professor, Anesthesiology and Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zirui Huang

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2R01GM103894-10A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00213014

Identifier Type: -

Identifier Source: org_study_id