HealthyNCT06426498
tFUS Induced Transient Scotoma for Individual Dosing
A study testing Brainsonix Bx Pulsar machine tFUS in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purposes of this research study is to: 1. Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured. 2. Use this technique to measure threshold for effective tFUS in individuals. 3. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brainsonix Bx Pulsar machine tFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 20 Aug 2027
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18-70
- Normal or corrected-to normal vision and hearing
- No neurological or psychological illness
Who cannot join
- Diagnosis of any depressive or anxiety disorder
- Diagnosis of schizophrenia or bipolar disorder
- Current use of any non-prescribed psychoactive medications or drugs
- Contraindication to enter the MRI environment.
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
- Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study include: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
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- Inability to adhere to treatment schedule.
- Initiation of new antidepressant treatment at the time of study randomization.
- NOTE: There will be no exclusion based upon gender or minority status. We anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. We will make vigorous attempts to increase this number by posting advertisement flyers in minority communities.
- Children, prisoners, and institutionalized individuals will not be recruited, because they are beyond the scope of the objectives. Moreover, we will emphasize that participation in this study is completely voluntary. Recruitment of women and minorities has been addressed above. Non-English speaking subjects will not be recruited because they may not be able to understand instructions, which could undermine the validity of the results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina Brain Stimulation Division
Charleston, South Carolina, 29425
Mark S George, MD, 843-876-5142, georgem@musc.edu
Baron E Short, MD, 843 876 5142, shorteb@musc.edu
About this study
Official title: Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment.
The purposes of this research study is to:
- Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured.
- Use this technique to measure threshold for effective tFUS in individuals.
- Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS.
Read the detailed description
Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person.
- Conditions
- Healthy
- Being tested
- Brainsonix Bx Pulsar machine tFUS
- Keywords
- ulltrasound, tFUS, scotoma, visual field
- Medical subject headings
- Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsonix Bx Pulsar machine tFUSDevice
This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines.
| Study group | Role | What they receive |
|---|---|---|
| tFUS over V1 | Experimental | All subjects will get tFUS, open label Receives: Device: Brainsonix Bx Pulsar machine tFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporary Scotoma
Production of a temporary Scotoma as assessed by visual field testing of briefly presented objects in different quadrants while staring at a central cross on a computer screen.
Measured: During and immediately after (10 minutes) the tFUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 Jun 2024
- Primary completion20 May 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark George, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426498
- Sponsor's protocol ID
- Pro00132894
- Status last verified
- May 2026
- First submitted
- 14 May 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment.
- ClinicalTrials.gov ID
- NCT06426498
- Acronym / sponsor ID
- Pro00132894
- Conditions
- Healthy
- Keywords
- ulltrasound, tFUS, scotoma, visual field
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 23 May 2024 (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 purposes of this research study is to:
- Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured.
- Use this technique to measure threshold for effective tFUS in individuals.
- Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS.
Detailed description
Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tFUS over V1 | Experimental | Device: Brainsonix Bx Pulsar machine tFUSAll subjects will get tFUS, open label |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18-70
- Normal or corrected-to normal vision and hearing
- No neurological or psychological illness
Key exclusion criteria (10 listed)
- Diagnosis of any depressive or anxiety disorder
- Diagnosis of schizophrenia or bipolar disorder
- Current use of any non-prescribed psychoactive medications or drugs
- Contraindication to enter the MRI environment.
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
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 |
|---|---|---|
| Brainsonix Bx Pulsar machine tFUSThis is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines. | Device | tFUS over V1 |
Primary outcome
Temporary Scotoma
Time frame: During and immediately after (10 minutes) the tFUS
Production of a temporary Scotoma as assessed by visual field testing of briefly presented objects in different quadrants while staring at a central cross on a computer screen.
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 29 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainsonix Bx Pulsar machine tFUS in people with Healthy, run by Medical University of South Carolina 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 May 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.
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?
Contact Bridgette Holland (843 638 7517, hollanbr@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporary Scotoma (time frame: During and immediately after (10 minutes) the tFUS). 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 29 May 2026.