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

NCT05303428 | Not Yet Recruiting

• 1 other identifier: 22-243
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

• fMRI Signals - Cognition

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

  Participant study duration, approximately 3 weeks.

Secondary Outcomes (1)

• Executive function task performance

  Participant study duration, approximately 3 weeks.

Other Outcomes (1)

• Assess for changes in physiological measures

  Participant study duration, approximately 3 weeks.

Study Arms (1)

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).

Other: Neuromodulation with low-intensity focused ultrasound

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.

LIFU, fMRI Cognitive

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Central Study Contacts

Jessica Florig, MPH

CONTACT

5405262375; legonlab@vtc.vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 31, 2022
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share