NCT05495945

Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mental Function

Interventions

Type	Name	Description
DEVICE	Low-intensity focused ultrasound pulsation (LIFUP)	LIFUP will be used to stimulate specific brain regions and assess their causal involvement in the control of conscious state and contents.
COMBINATION_PRODUCT	Functional Magnetic Resonance Imaging (fMRI) using Propofol	Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-10-07
• Completion: 2023-10-07
• First posted: 2022-08-10
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study