Healthy ParticipantsNCT07220655
Cognition and Ultrasound
A study testing Low-Intensity Focused Ultrasound (FUS or LIFU) in people with Healthy Participants, run by University of Minnesota at 1 site in United States.
Trial summary
Our primary goal is to investigate the role of Low-Intensity Focused Ultrasound (LIFU) neuromodulation on deep brain targets, and its potential to improve cognition Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Low-Intensity Focused Ultrasound (FUS or LIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Jul 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Speak English (as assessed by their ability to read/answer survey questions)
- May be required to score in the appropriate range on self-report measures
Who cannot join
- They have a neurological disorder which may impact their fMRI scan or cause their reaction to LIFU to differ from that of healthy adults.
- They take any psychoactive medication.
- They are unable to undergo fMRI scanning due to a contraindication such as claustrophobia, unremovable piercings, pregnancy, the presence of medical devices such as pacemakers, or a movement or sleep disorder.
- Are pregnant, or may have reason to believe that they are pregnant.
- They have a diagnosis of a psychiatric condition other than depression or anxiety
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
University of Minnesota
Minneapolis, Minnesota, 55455
Miriam Freedman, 612-625-3330, bronsteinlab@umn.edu
About this study
Our primary goal is to investigate the role of Low-Intensity Focused Ultrasound (LIFU) neuromodulation on deep brain targets, and its potential to improve cognition
- Conditions
- Healthy Participants
- Being tested
- Low-Intensity Focused Ultrasound (FUS or LIFU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused Ultrasound (FUS or LIFU)Device
We will use an established, currently-marketed device to deliver LIFU neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Focused Ultrasound | Experimental | Not described Receives: Device: Low-Intensity Focused Ultrasound (FUS or LIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Brain Targets Reached
MRI-based readouts testing whether LIFU neuromodulation can successfully engage targets in deep brain
Measured: Hour 1
Multi-Source Interference Test (MSIT) Performance
Behavioral readouts of successful LIFU neuromodulation of our target regions
Measured: Hour 1
28/Posit Science Performance
Behavioral readouts of successful LIFU neuromodulation of our target regions
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start1 Jun 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bronstein, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220655
- Sponsor's protocol ID
- PSYCH-2024-33067
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2025
- Last updated
- 15 Jun 2026
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Ultrasound
- ClinicalTrials.gov ID
- NCT07220655
- Acronym / sponsor ID
- PSYCH-2024-33067
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 24 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.
Our primary goal is to investigate the role of Low-Intensity Focused Ultrasound (LIFU) neuromodulation on deep brain targets, and its potential to improve cognition
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Focused Ultrasound | Experimental | Device: Low-Intensity Focused Ultrasound (FUS or LIFU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Speak English (as assessed by their ability to read/answer survey questions)
- May be required to score in the appropriate range on self-report measures
Key exclusion criteria (5 listed)
- They have a neurological disorder which may impact their fMRI scan or cause their reaction to LIFU to differ from that of healthy adults.
- They take any psychoactive medication.
- They are unable to undergo fMRI scanning due to a contraindication such as claustrophobia, unremovable piercings, pregnancy, the presence of medical devices such as pacemakers, or a movement or sleep disorder.
- Are pregnant, or may have reason to believe that they are pregnant.
- They have a diagnosis of a psychiatric condition other than depression or anxiety
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 Focused Ultrasound (FUS or LIFU)We will use an established, currently-marketed device to deliver LIFU neuromodulation. | Device | Low-Intensity Focused Ultrasound |
Primary outcome
Deep Brain Targets Reached
Time frame: Hour 1
MRI-based readouts testing whether LIFU neuromodulation can successfully engage targets in deep brain
Multi-Source Interference Test (MSIT) Performance
Time frame: Hour 1
Behavioral readouts of successful LIFU neuromodulation of our target regions
28/Posit Science Performance
Time frame: Hour 1
Behavioral readouts of successful LIFU neuromodulation of our target regions
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 15 Jun 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.
Michael Bronstein principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Focused Ultrasound (FUS or LIFU) in people with Healthy Participants, run by University of Minnesota 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 3 inclusion and 5 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 15 Jun 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 Miriam Freedman (tel:612-625-3330, bronsteinlab@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep Brain Targets Reached (time frame: Hour 1). The study lists 3 primary outcomes in all. 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 15 Jun 2026.