Phase 2
Completed N=8
Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Mental Function
Source: ClinicalTrials.gov NCT05495945 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli — 0.56; 0.51 percentage of BOLD signal — p=0.62
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli |
0.56; 0.51 | 0.62 |
| SECONDARY Perceptual Criterion Derived From the Signal Detection Theory (SDT) |
0.56; 0.80 | 0.18 |
| SECONDARY Sensitivity Derived From the Signal Detection Theory (SDT) |
0.72; 0.39 | 0.20 |
| SECONDARY Grip Force |
13.8; 11.9 | 0.02 sig |
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.
Data sourced from ClinicalTrials.gov (NCT05495945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.