Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

Обзор

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.

Подробное описание

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."

Вмешательства

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

Первичные конечные точки

• Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses [Срок оценки: Up to 90 minutes]

Вторичные конечные точки (1)

• Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions [Срок оценки: Up to 90 minutes]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07221539 · HUM00251770 · R01GM103894

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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