Characterizing Transcranial Focused Ultrasound Neuromodulation During Sedation

NCT07161518 | Enrolling By Invitation Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 79882
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Electroencephalographic power spectral density

  Electroencephalographic (EEG) power will be computed using the multitaper spectrogram method applied to frontal, central, and posterior EEG leads and will be reported in the 0.5 Hz (delta) to 40 Hz (gamma) range inclusive of all bands therein (delta, theta, alpha, beta, gamma).

  3 hour period concurrent with delivery of propofol anesthesia

Secondary Outcomes (6)

• Percent responsiveness to commands

  3 hours concurrent with delivery of propofol anesthesia

• Reaction time to verbal commands

  3 hours concurrent with delivery of propofol anesthesia

• Reaction time in visual psychomotor vigilance test

  Prior to delivery of propofol anesthesia, directly upon cessation of propofol anesthesia, and 15 minutes following cessation of propofol anesthesia

• Number of trials completed in 90-second digit symbol substitution test

  Prior to delivery of propofol anesthesia, directly upon cessation of propofol anesthesia, and 15 minutes following cessation of propofol anesthesia

• Pressure pain threshold

  15 minutes preceding the start of, and following cessation of, delivery of propofol anesthesia

Study Arms (2)

Active then Sham

EXPERIMENTAL

Active (focused) ultrasound followed by washout of 5 days or greater, followed by sham (unfocused) ultrasound

Device: Low-intensity transcranial ultrasound; Drug: Propofol

Sham then Active

EXPERIMENTAL

Sham (unfocused) ultrasound followed by washout of 5 days or greater, followed by active (focused) ultrasound

Device: Low-intensity transcranial ultrasound; Drug: Propofol

Interventions

Propofol DRUG

Intravenous propofol administration

Active then Sham; Sham then Active

Low-intensity transcranial ultrasound DEVICE

Active (focused) ultrasound

Active then Sham; Sham then Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 65 years of age, inclusive, at time of screening.
• Body mass index between 17-35 kg/m2.
• Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
• If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
• Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or
• Childbearing potential, and meets the following criteria:
• (i) Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at enrollment prior to receiving study treatment.
• (ii) Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline.

You may not qualify if:

• Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
• Female that is pregnant or breastfeeding.
• Female with a positive pregnancy test at screening or baseline.
• Current diagnosis of Axis I or II disorders other than Major Depressive Disorders, Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Somatization Disorder, Pain Disorder, Sexual and Gender Identity Disorders, Insomnia, Adjustment Disorders, Tic Disorders, and Neurodevelopmental Disorders.
• Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more) History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
• Any neurological disorder including:
• Dementia, delirium, amnestic, or any other cognitive disorder
• Lifetime history of surgical procedures involving the brain or meninges
• Encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, developmental delay
• Any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS),
• History of significant head trauma resulting in cognitive impairment within the past two years.
• Any cardiovascular disorder including:
• Uncontrolled hypertension
• Congestive heart failure NYHA Criteria \>Stage 2
• Atrial fibrillation or resting heart rate \<50 or \>105 beats per minute at screening

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)