Cognitive ChangeNCT05303428
Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals
A study testing Neuromodulation with low-intensity focused ultrasound in people with Cognitive Change, run by Virginia Polytechnic Institute and State University.
Trial summary
Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Neuromodulation with low-intensity focused ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, all ethnicities, who understand and speak English.
Who cannot join
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.
- Conditions
- Cognitive Change
- Being tested
- Neuromodulation with low-intensity focused ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation with low-intensity focused ultrasoundOther
application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.
| Study group | Role | What they receive |
|---|---|---|
| LIFU, fMRI Cognitive | Experimental | fMRI resting and cognitive tasks performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested). Receives: Other: Neuromodulation with low-intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Signals - Cognition
Changes in fMRI signals of region of interest during a cognitive task
Measured: Participant study duration, approximately 3 weeks.
Secondary outcomes (1)
Executive function task performance
Testing effects of LIFU on altered task performance
Measured: Participant study duration, approximately 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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
- NCT05303428
- Sponsor's protocol ID
- 22-243
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals
- ClinicalTrials.gov ID
- NCT05303428
- Acronym / sponsor ID
- 22-243
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 31 Mar 2022 (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.
Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFU, fMRI Cognitive | Experimental | Other: Neuromodulation with low-intensity focused ultrasoundfMRI resting and cognitive tasks performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers, all ethnicities, who understand and speak English.
Key exclusion criteria (7 listed)
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
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 |
|---|---|---|
| Neuromodulation with low-intensity focused ultrasoundapplication of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning. | Other | LIFU, fMRI Cognitive |
Primary outcome
fMRI Signals - Cognition
Time frame: Participant study duration, approximately 3 weeks.
Changes in fMRI signals of region of interest during a cognitive task
1 secondary outcome
Executive function task performance
Time frame: Participant study duration, approximately 3 weeks.
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 9 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation with low-intensity focused ultrasound in people with Cognitive Change, run by Virginia Polytechnic Institute and State University.
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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jessica Florig, MPH (5405262375, legonlab@vtc.vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Signals - Cognition (time frame: Participant study duration, approximately 3 weeks.). 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 9 Dec 2025.