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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05303428
Enrollment
80
Registered
2022-03-31
Start date
2026-10-31
Completion date
2028-04-30
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

Brief 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.

Interventions

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

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frameDescription
fMRI Signals - CognitionParticipant study duration, approximately 3 weeks.Changes in fMRI signals of region of interest during a cognitive task

Secondary

MeasureTime frameDescription
Executive function task performanceParticipant study duration, approximately 3 weeks.Testing effects of LIFU on altered task performance

Other

MeasureTime frameDescription
Assess for changes in physiological measuresParticipant study duration, approximately 3 weeks.Monitoring for any changes in heartrate, blood pressure, respiratory rate, or galvanic skin response throughout testing

Contacts

Primary ContactJessica Florig, MPH
legonlab@vtc.vt.edu5405262375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026