Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke (LIFU-IVR)

May 19, 2026 updated by: Duke University

This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy.

The purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomization visit and 1st Intervention visit:

The randomization visit and 1st intervention vision will be on the same day. Participants will be "randomized" into one of the study groups described below.

  • Group 1 (Sham Group): Inactive LIFU + VR
  • Group 2 (Active Group): LIFU + VR Neither the subject nor the researcher conducting this study will know which group participants are in.

Sham LIFU: The setup is similar for the active stimulation group, except that a high acoustic impedance disk will be placed between the LIFU probe and the scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. The audible sound is nearly identical for both the sham and active stimulation.

Intervention visits (9 sessions over 21 days, about 2.5 hours per visit):

At these visits, participants will undergo the investigational study interventions.

There will be 30 minutes of a VR session and 20 minutes of active LIFU or inactive LIFU treatments.

Study Type

Interventional

Enrollment (Estimated)

28

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 Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

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

No

Description

Inclusion Criteria:

  • ≥ 18 years old of any gender and race
  • Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 6-24 months ago
  • Partial or complete homonymous hemianopsia on clinical exam

Exclusion Criteria:

  • Documented history of severe dementia with or without medication before stroke that affect subject's ability to participate in and be compliant to study protocol
  • Significant upper motor deficits and the subject cannot do IVR sessions at the baseline
  • History of seizures
  • Inability to get a new MRI
  • Presence of any ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of ultrasonic stimulation on the fetus is unknown); preexisting scalp lesion or wound or bone defect or hemicraniectomy.
  • Patients will be excluded if they have a previous diagnosis of hemianopsia, a new diagnosis of central retinal ischemic injury, or visual blindness or a history of any other ocular disease.
  • Concerns about the inability to complete study visits/procedures by the PI.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFUS with IVR
Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy.
Device: Low-intensity focused ultrasound
Low-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain.
Other Names:
  • LIFU
Device: Immersive virtual reality
IVR is a noninvasive, computer-based audiovisual therapy designed to enhance visual function. Using a VR headset, the system delivers targeted visual stimulation through an interactive game that the participant engages with during each session.
Other Names:
  • IVR
Sham Comparator: Inactive LIFUS with IVR
The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy
Device: Immersive virtual reality
IVR is a noninvasive, computer-based audiovisual therapy designed to enhance visual function. Using a VR headset, the system delivers targeted visual stimulation through an interactive game that the participant engages with during each session.
Other Names:
  • IVR
Device: Inactive Low-intensity focused ultrasound
High acoustic impedance disk placed between LIFU and scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Field Change
Time Frame: From enrollment to the 30 days after the end of treatment.
Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset
From enrollment to the 30 days after the end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Change
Time Frame: From enrollment to the 30 days after the end of treatment.
Change as assessed by the National Eye Institute 25 Item Visual Function Questionnaire (NEI-VFQ 25). The NEI-VFQ is a vision based questionnaire which evaluates quality of life with respect to vision in everyday life. The NEI-VFQ has multiple sub-scales for different areas of life, such as Near-Vision, General Health, or Ocular Pain. Each scale is scored from 0 to 100 with 100 representing the best possible score (perfect health or ability)
From enrollment to the 30 days after the end of treatment.
Hemodynamic response change
Time Frame: From enrollment to the 30 days after the end of treatment.
Change in oxygenated hemoglobin concentration or blood-oxygen-level-dependent (BOLD) signal response from baseline and after intervention
From enrollment to the 30 days after the end of treatment.

Collaborators and Investigators

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

Sponsor

Duke 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)

December 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115941

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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