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Not yet recruitingNCT05303428Updated Dec 9, 2025

Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals

An interventional study of Neuromodulation with low-intensity focused ultrasound in Cognitive Change, sponsored by Virginia Polytechnic Institute and State University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Cognitive Change
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In context

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers, all ethnicities, who understand and speak English.

Exclusion criteria

Exclusion Criteria:

  1. Claustrophobia (scanning environment may be uncomfortable).
  2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Contraindications to CT: pregnancy
  4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
  5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
  6. History of head injury resulting in loss of consciousness for >10 minutes.
  7. History of alcohol or drug dependence (through self-report).
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    LIFU, fMRI Cognitive

    fMRI resting and cognitive tasks performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).

    Other: Neuromodulation with low-intensity focused ultrasound

Interventions

  • OtherNeuromodulation with low-intensity focused ultrasound

    application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.

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What researchers measure

Primary outcomes

  1. fMRI Signals - Cognition

    Changes in fMRI signals of region of interest during a cognitive task

    Time frame: Participant study duration, approximately 3 weeks.

Secondary outcomes

  1. Executive function task performance

    Testing effects of LIFU on altered task performance

    Time frame: Participant study duration, approximately 3 weeks.

Other outcomes

  1. Assess for changes in physiological measures

    Monitoring for any changes in heartrate, blood pressure, respiratory rate, or galvanic skin response throughout testing

    Time frame: Participant study duration, approximately 3 weeks.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05303428
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
Wynn Legon (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Mar 31, 2022
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Dec 9, 2025

Study contacts

Jessica Florig, MPH
Contact
legonlab@vtc.vt.edu
5405262375

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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