Brain ImagingNCT07222865
tFUS Imaging & LIFU
A study testing Feasibility of imaging using tFUS in people with Brain Imaging, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
This study is investigating a new method of brain imaging - transcranial functional ultrasound (tFUS). We are comparing the imaging capabilities with functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Imaging
- What is being tested?
- Feasibility of imaging using tFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- See above.
Who cannot join
- Claustrophobia
- Contraindications to MRI (neurostims, metal implants, pacemakers, etc)
- Contraindications to CT (pregnancy)
- Active medical disorders with CNS effects (e.g. Alzheimers)
- History of neurological disorder
- History of head injury with LOC > 10 min
- History of alcohol or drug dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Towards Realtime High-resolution Treatment Monitoring in Humans: Using Ultrasound Imaging to Monitor Low-intensity Focused Ultrasound Neuromodulation
This study is investigating a new method of brain imaging - transcranial functional ultrasound (tFUS). We are comparing the imaging capabilities with functional magnetic resonance imaging (fMRI).
Read the detailed description
A battery of tasks will be performed under two imaging conditions. Magnetic Resonance Imaging and transcranial functional ultrasound imaging. Tasks include a breath hold task, an e-stim task, and low-intensity focused ultrasound neuromod.
- Conditions
- Brain Imaging
- Being tested
- Feasibility of imaging using tFUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of imaging using tFUSDevice
Imaging using transcranial functional ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - all participants | Experimental | All participants will receive two imaging modalities with corresponding tasks to compare imaging modalities. Receives: Device: Feasibility of imaging using tFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting task-evoked changes
Detecting task-evoked changes using tFUS imaging
Measured: The duration of each task - ~10 minutes.
Secondary outcomes (1)
Detecting LIFU induced neural activity
Detection in changes of neural activity during LIFU using tFUS
Measured: During LIFU application, ~2 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: Study does not need to be registered. Study team wishes to withdraw registration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ImagingStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete all study visits - fMRI + tasks, tFUS + tasks, and tFUS + LIFU.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222865
- Sponsor's protocol ID
- 25-953
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Realtime High-resolution Treatment Monitoring in Humans: Using Ultrasound Imaging to Monitor Low-intensity Focused Ultrasound Neuromodulation
- ClinicalTrials.gov ID
- NCT07222865
- Acronym / sponsor ID
- 25-953
- Conditions
- Brain Imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study does not need to be registered. Study team wishes to withdraw registration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Oct 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.
This study is investigating a new method of brain imaging - transcranial functional ultrasound (tFUS). We are comparing the imaging capabilities with functional magnetic resonance imaging (fMRI).
Detailed description
A battery of tasks will be performed under two imaging conditions. Magnetic Resonance Imaging and transcranial functional ultrasound imaging. Tasks include a breath hold task, an e-stim task, and low-intensity focused ultrasound neuromod.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete all study visits - fMRI + tasks, tFUS + tasks, and tFUS + LIFU.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - all participants | Experimental | Device: Feasibility of imaging using tFUSAll participants will receive two imaging modalities with corresponding tasks to compare imaging modalities. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- See above.
Key exclusion criteria (7 listed)
- Claustrophobia
- Contraindications to MRI (neurostims, metal implants, pacemakers, etc)
- Contraindications to CT (pregnancy)
- Active medical disorders with CNS effects (e.g. Alzheimers)
- History of neurological disorder
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 |
|---|---|---|
| Feasibility of imaging using tFUSImaging using transcranial functional ultrasound. | Device | Arm 1 - all participants |
Primary outcome
Detecting task-evoked changes
Time frame: The duration of each task - ~10 minutes.
Detecting task-evoked changes using tFUS imaging
1 secondary outcome
Detecting LIFU induced neural activity
Time frame: During LIFU application, ~2 min.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- 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. This study is not recruiting at the moment.
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 study testing Feasibility of imaging using tFUS in people with Brain Imaging, run by Virginia Polytechnic Institute and State 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detecting task-evoked changes (time frame: The duration of each task - ~10 minutes.). 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 30 Oct 2025.