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

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT05303428
Status
Not Yet Recruiting

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Conditions

  • Cognitive Change

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Neuromodulation with low-intensity focused ultrasound — OTHER
    application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.

Study Details

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.

Key Dates

First listed
Mar 31, 2022
Start date
Oct 31, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

fMRI Signals - Cognition [ Time Frame: Participant study duration, approximately 3 weeks. ]

Central Contacts

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