Characterizing Transcranial Focused Ultrasound Neuromodulation During Sedation

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07161518
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Low-intensity transcranial ultrasound — DEVICE
    Active (focused) ultrasound
  • Low-intensity transcranial ultrasound — DEVICE
    Sham (unfocused) ultrasound
  • Propofol — DRUG
    Intravenous propofol administration

Study Details

The goal of this clinical trial is to learn if focused ultrasound delivered to the brain influences the effects of the anesthetic medication propofol. It will also learn about the safety and feasibility of using ultrasound and anesthesia together to influence the brain. The main questions it aims to answer are: * Does focused ultrasound delivered to the brain influence the effects or the strength of propofol? * Does propofol anesthesia influence the effects of ultrasound delivered to the brain? Researchers will compare focused ultrasound with sham ultrasound (similar technology but not targeted to a brain region) and administer propofol anesthesia, while measuring signals from the brain and behaviors of participants. Participants will: * Obtain one non-contrast MRI scan of the brain * Receive two separate sessions of ultrasound to the brain (one focused and one sham) * Undergo two separate sessions of propofol anesthesia in a laboratory

Key Dates

Start date
Sep 1, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active then Sham
    Active (focused) ultrasound followed by washout of 5 days or greater, followed by sham (unfocused) ultrasound
  • Experimental: Sham then Active
    Sham (unfocused) ultrasound followed by washout of 5 days or greater, followed by active (focused) ultrasound

Primary Outcome Measure

Electroencephalographic power spectral density [ Time Frame: 3 hour period concurrent with delivery of propofol anesthesia ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-

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