Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

NCT05495945 | Completed Phase 2 Results FDA Drug FDA Device

• 2 other identifiers: HUM002130142R01GM103894-10A1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Function

Keywords

Propofol; Anesthesia; Ultrasound; fMRI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Perceptual Criterion Derived From the Signal Detection Theory (SDT)

  Up to 90 minutes

• Sensitivity Derived From the Signal Detection Theory (SDT)

  Up to 90 minutes

• Grip Force

  Up to 90 minutes

Study Arms (4)

Dorsolateral prefrontal cortex (DLPFC)

EXPERIMENTAL

Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol

Anterior insula cortex (AIC)

EXPERIMENTAL

Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol

Central thalamus (CT)

EXPERIMENTAL

Device: Low-intensity focused ultrasound pulsation (LIFUP); Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol

Sham control

ACTIVE COMPARATOR

Combination Product: Functional Magnetic Resonance Imaging (fMRI) using Propofol

Interventions

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.

Anterior insula cortex (AIC); Central thalamus (CT); Dorsolateral prefrontal cortex (DLPFC)

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

Also known as: Diprivan

Anterior insula cortex (AIC); Central thalamus (CT); Dorsolateral prefrontal cortex (DLPFC); Sham control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Zirui Huang
• Organization: University of Michigan

huangzu@med.umich.edu

(734) 615-2875

Study Officials

• Zirui Huang

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor, Anesthesiology and Research Fellow

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 26, 2022
• Primary Completion: October 7, 2023
• Study Completion: October 7, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)