Healthy ParticipantsPhase 4NCT07161518
Characterizing Transcranial Focused Ultrasound Neuromodulation During Sedation
A Phase 4 study testing Low-intensity transcranial ultrasound and Propofol in people with Healthy Participants, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Low-intensity transcranial ultrasound and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at enrollment prior to receiving study treatment.
- 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.
Who cannot join
- 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:
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- 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
- Clinicially significant uncontrolled arrhythmia
- QTcF (Fridericia-corrected) >= 450 msec at screening
- Any cardiovascular disorder that would merit categorization of patient as ASA Class 3 or higher
- Any pulmonary/respiratory disorder including:
- Formally diagnosed obstructive sleep apnea (OSA) that is moderate and not treated with a CPAP machine; or formally diagnosed OSA that is severe, regardless of treatment
- Undiagnosed OSA with a STOPBANG score of 5 or higher
- History of difficult airway in surgical setting
- Any pulmonary/respiratory disorder that would merit categorization of patient as ASA Class 3 or higher
- Clinically significant liver disease, determined by LFTs within the past 6 months
- Clinically significant kidney disease determined by creatinine / GFR within the past 6 months
- Symptomatic gastroesophageal reflux disease, hiatal hernia, taking medications causing delayed gastric emptying, or any other gastrointestinal disorder placing the patient at risk for aspiration or that would merit categorization of patient as ASA physical classification status of III or higher
- Any endocrine disorder including:
- Uncontrolled diabetes mellitus, type 1 or 2
- Clinically significant hypothyroidism or hyperthyroidism which has not been stably treated for at least 6 months
- Any other endocrine disorder that would merit categorization of patient as ASA Class 3 or higher
- Patients taking any of the following daily medications:
- Opioids including buprenorphine and methadone
- Naltrexone or other opioid antagonist
- Clonidine
- Any other clinically significant abnormal laboratory result at the time of the screening exam that might affect safety, study participation or confound interpretation of study results
- Any other clinically significant physical exam abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA Class 3 or higher
- Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.
- Abnormalities noted on anatomy mapping brain MRI as determined by radiologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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
- Being tested
- Low-intensity transcranial ultrasound, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity transcranial ultrasoundDevice
Active (focused) ultrasound
Low-intensity transcranial ultrasoundDevice
Sham (unfocused) ultrasound
PropofolDrug
Intravenous propofol administration
| Study group | Role | What they receive |
|---|---|---|
| Active then Sham | Experimental | Active (focused) ultrasound followed by washout of 5 days or greater, followed by sham (unfocused) ultrasound Receives: 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 Receives: Device: Low-intensity transcranial ultrasound; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 hour period concurrent with delivery of propofol anesthesia
Secondary outcomes (6)
Percent responsiveness to commands
Measured via electronically delivered commands and electronically monitored response button
Measured: 3 hours concurrent with delivery of propofol anesthesia
Reaction time to verbal commands
Measured via electronically delivered verbal commands and electronically monitored response button
Measured: 3 hours concurrent with delivery of propofol anesthesia
Reaction time in visual psychomotor vigilance test
Delivered via computer screen and button
Measured: 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
Using a standardized protocol for the digit symbol substitution test delivered via computer screen and keyboard for participant responses
Measured: Prior to delivery of propofol anesthesia, directly upon cessation of propofol anesthesia, and 15 minutes following cessation of propofol anesthesia
Pressure pain threshold
Measured via quantitative algometer testing on the trapezius muscle
Measured: 15 minutes preceding the start of, and following cessation of, delivery of propofol anesthesia
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).
Measured: 15 minutes preceding the start of, and following cessation of, delivery of propofol anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris D. Heifets, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161518
- Sponsor's protocol ID
- 79882
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Transcranial Focused Ultrasound Neuromodulation During Sedation
- ClinicalTrials.gov ID
- NCT07161518
- Acronym / sponsor ID
- 79882
- Conditions
- Healthy Participants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active then Sham | Experimental | Device: Low-intensity transcranial ultrasound, Drug: PropofolActive (focused) ultrasound followed by washout of 5 days or greater, followed by sham (unfocused) ultrasound |
| Sham then Active | Experimental | Device: Low-intensity transcranial ultrasound, Drug: PropofolSham (unfocused) ultrasound followed by washout of 5 days or greater, followed by active (focused) ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity transcranial ultrasoundActive (focused) ultrasound | Device | Active then Sham, Sham then Active |
| Low-intensity transcranial ultrasoundSham (unfocused) ultrasound | Device | Active then Sham, Sham then Active |
| PropofolIntravenous propofol administration | Drug | Active then Sham, Sham then Active |
Primary outcome
Electroencephalographic power spectral density
Time frame: 3 hour period concurrent with delivery of propofol anesthesia
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).
6 secondary outcomes
Percent responsiveness to commands
Time frame: 3 hours concurrent with delivery of propofol anesthesia
Reaction time to verbal commands
Time frame: 3 hours concurrent with delivery of propofol anesthesia
Reaction time in visual psychomotor vigilance test
Time frame: 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
Time frame: Prior to delivery of propofol anesthesia, directly upon cessation of propofol anesthesia, and 15 minutes following cessation of propofol anesthesia
Pressure pain threshold
Time frame: 15 minutes preceding the start of, and following cessation of, delivery of propofol anesthesia
Electroencephalographic power spectral density
Time frame: 15 minutes preceding the start of, and following cessation of, delivery of propofol anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-intensity transcranial ultrasound and Propofol in people with Healthy Participants, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalographic power spectral density (time frame: 3 hour period concurrent with delivery of propofol anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.