Clinical trial NCT05495945: Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Official title: Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mental Function
Keywords: Propofol
Anesthesia
Ultrasound
fMRI
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-08-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Perceptual Criterion Derived From the Signal Detection Theory (SDT)
timeFrame: Up to 90 minutes
measure: Sensitivity Derived From the Signal Detection Theory (SDT)
timeFrame: Up to 90 minutes
measure: Grip Force
timeFrame: Up to 90 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Zirui Huang
role: PRINCIPAL_INVESTIGATOR
References: