NCT06875206

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-03-13
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study