tFUS Imaging & LIFU | NCT07222865

Studies
tFUS Imaging & LIFU

NCT07222865

Sponsor

Virginia Polytechnic Institute and State University

Status

Withdrawn

Last Update Posted

Oct 30, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Brain Imaging

Interventions

Feasibility of imaging using tFUS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study does not need to be registered. Study team wishes to withdraw registration

Expanded Access Info

Start Date

Jan 2026Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Oct 1, 2025

First Submission Date that Met QC Criteria

Oct 29, 2025

First Posted Date

Oct 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2025

Last Update Posted Date

Oct 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State UniversityPrincipal Investigator

Lead Sponsor

Virginia Polytechnic Institute and State UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 - all participants	Experimental	All participants will receive two imaging modalities with corresponding tasks to compare imaging modalities.	Device: Feasibility of imaging using tFUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feasibility of imaging using tFUS	Device	Imaging using transcranial functional ultrasound.	Arm 1 - all participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fralin Biomedical Research Institute at VTC		Roanoke	Virginia	24016	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided