Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke

NCT ID: NCT06875206

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-04-30

Brief Summary

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.

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.

Conditions

Stroke; Visual Field Defect; Visual Field Defect Following Cerebrovascular Accident; Hemianopia; Quadrantanopia; Occipital Lobe Infarct; Visual Fields Hemianopsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-intensity focused ultrasound

Intervention Type: DEVICE

Low-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain.

Immersive virtual reality

Intervention Type: DEVICE

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.

Inactive LIFUS with IVR

The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy

Group Type: SHAM_COMPARATOR

Immersive virtual reality

Intervention Type: DEVICE

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.

Inactive Low-intensity focused ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

LIFU; IVR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Central Contacts

Megan Gonzalez, MSCR

Role: CONTACT

megan.gonzalez@duke.edu

919-668-7597

Shashank Shekhar, MD

Role: CONTACT

shashank.shekhar@duke.edu

9196687597

Other Identifiers

Pro00115941

Identifier Type: -

Identifier Source: org_study_id