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

NCT ID: NCT05303428

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-31
• Study Completion Date: 2028-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Neuromodulation with low-intensity focused ultrasound

Intervention Type: OTHER

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

Interventions

Neuromodulation with low-intensity focused ultrasound

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Wynn Legon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jessica Florig, MPH

Role: CONTACT

legonlab@vtc.vt.edu

5405262375

Other Identifiers

22-243

Identifier Type: -

Identifier Source: org_study_id