NCT07222865

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
25mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Jun 2028

First Submitted

Initial submission to the registry

October 1, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

October 1, 2025

Last Update Submit

October 29, 2025

Conditions

Brain Imaging

Outcome Measures

Primary Outcomes (1)

  • Detecting task-evoked changes

    Detecting task-evoked changes using tFUS imaging

    The duration of each task - ~10 minutes.

Secondary Outcomes (1)

  • Detecting LIFU induced neural activity

    During LIFU application, ~2 min.

Study Arms (1)

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

Feasibility of imaging using tFUSDEVICE

Imaging using transcranial functional ultrasound.

Arm 1 - all participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • See above.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: All participants will complete all study visits - fMRI + tasks, tFUS + tasks, and tFUS + LIFU.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 30, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)