Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Mental Function

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05495945

HUM00213014

2R01GM103894-10A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Dorsolateral prefrontal cortex (DLPFC)

Experimental group

Treatment:

Device: Low-intensity focused ultrasound pulsation (LIFUP)

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

Anterior insula cortex (AIC)

Experimental group

Treatment:

Device: Low-intensity focused ultrasound pulsation (LIFUP)

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

Central thalamus (CT)

Experimental group

Treatment:

Device: Low-intensity focused ultrasound pulsation (LIFUP)

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

Sham control

Active Comparator group

Treatment:

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