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Recruiting NCT07221539

Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

No phase Interventional Mental Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol for fMRI, Dexmedetomidine for fMRI, Dorsolateral prefrontal cortex (DLPFC) pulsation, Anterior insular cortex (AIC) pulsation.
Who it may be relevant to
Registry conditions: Mental Function. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to see if mental functions take place during different levels of anesthesia using two commonly used drug (propofol and dexmedetomidine) and will include low-intensity focused ultrasound pulsation (LIFUP) to stimulate specific areas of the brain while undergoing functional Magnetic Resonance Imaging (fMRI or "brain imaging"), which shows areas in the brain involved in thinking at different depths of anesthesia. That is, ultrasound is being used to stimulate the brain and multiple pictures will be taken of the brain. As a result of this study, we 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 FDA determined this trial is a non-significant risk (NSR) device study. Although Propofol and Dexmedetomidine, which are FDA-approved drugs for use in patients undergoing an anesthetic for medical treatment, will be used in this trial, the FDA determined that the trial will not be studying these drugs. Rather, the FDA determined this trial will be studying the NSR device. To ensure consistency with the FDA's determination, the field for "U.S. FDA-regulated Drug" in this record has been marked as "No."

Interventions

  • Procedure Propofol for fMRI
    Propofol infusion
  • Procedure Dexmedetomidine for fMRI
    Dexmedetomidine infusion
  • Device Dorsolateral prefrontal cortex (DLPFC) pulsation
    BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC
  • Device Anterior insular cortex (AIC) pulsation
    BXPulsar 1002 LIFUP to AIC
  • Device Central thalamus (CT) pulsation
    BXPulsar 1002 LIFUP to CT

Primary outcome measures

  • Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses [Time frame: Up to 90 minutes]
Secondary outcome measures (1)
  • Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions [Time frame: Up to 90 minutes]

Eligibility criteria

Inclusion criteria

  • Healthy study participants with American Society of Anesthesiologists (ASA) Physical Status Classification System-1 status
  • The participants will be right-handed adults
  • Body mass index (BMI) less than 30.
  • All subjects will be English speakers.

Exclusion criteria

  • Medical contraindication to MRI scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
  • BMI>30,
  • metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans.
  • History of allergy to propofol, dexmedetomidine, any components of propofol or dexmedetomidine, eggs or egg products, soybean or soybean products,
  • Neurological, cardiovascular, or pulmonary illness;
  • Significant 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; epilepsy/seizure disorder (including a history of seizures) or stroke (including a history of stroke).
  • 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.
  • Recent food or liquid intake (within 8 hours).
  • 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. -----Negative pregnancy test result, if applicable.
  • Potential participants who have participated in a clinical trial using an investigational drug or device within 30 days will be considered for enrollment after 30 days.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07221539 · HUM00251770 · R01GM103894

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗