tFUS Imaging & LIFU

October 29, 2025 updated by: Wynn Legon, Virginia Polytechnic Institute and State University

Towards Realtime High-resolution Treatment Monitoring in Humans: Using Ultrasound Imaging to Monitor Low-intensity Focused Ultrasound Neuromodulation

This study is investigating a new method of brain imaging - transcranial functional ultrasound (tFUS). We are comparing the imaging capabilities with functional magnetic resonance imaging (fMRI).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A battery of tasks will be performed under two imaging conditions. Magnetic Resonance Imaging and transcranial functional ultrasound imaging. Tasks include a breath hold task, an e-stim task, and low-intensity focused ultrasound neuromod.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • See above.

Exclusion Criteria:

  • Claustrophobia
  • Contraindications to MRI (neurostims, metal implants, pacemakers, etc)
  • Contraindications to CT (pregnancy)
  • Active medical disorders with CNS effects (e.g. Alzheimers)
  • History of neurological disorder
  • History of head injury with LOC > 10 min
  • History of alcohol or drug dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - all participants
All participants will receive two imaging modalities with corresponding tasks to compare imaging modalities.
Device: Feasibility of imaging using tFUS
Imaging using transcranial functional ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detecting task-evoked changes
Time Frame: The duration of each task - ~10 minutes.
Detecting task-evoked changes using tFUS imaging
The duration of each task - ~10 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detecting LIFU induced neural activity
Time Frame: During LIFU application, ~2 min.
Detection in changes of neural activity during LIFU using tFUS
During LIFU application, ~2 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Estimated)

October 30, 2025

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 25-953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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