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

NCT06875206 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro00115941
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

virtual reality; stroke; visual deficit; chronic stroke; ultrasound stimulation; neuromodulation; stroke recovery; visual field defect; funcational imaging

Outcome Measures

Primary Outcomes (1)

• Visual Field Change

  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 Outcomes (2)

• Quality of Life Change

  From enrollment to the 30 days after the end of treatment.

• Hemodynamic response change

  From enrollment to the 30 days after the end of treatment.

Study Arms (2)

LIFUS with IVR

EXPERIMENTAL

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; Device: Immersive virtual reality

Inactive LIFUS with IVR

SHAM COMPARATOR

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

Device: Immersive virtual reality; Device: Inactive Low-intensity focused ultrasound

Interventions

Immersive virtual reality 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.

Also known as: IVR

Inactive LIFUS with IVR; LIFUS with IVR

Inactive Low-intensity focused ultrasound 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.

Inactive LIFUS with IVR

Low-intensity focused ultrasound DEVICE

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

Also known as: LIFU

LIFUS with IVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Stroke; Hemianopsia; Vision Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Megan Gonzalez, MSCR

CONTACT

919-668-7597; megan.gonzalez@duke.edu

Shashank Shekhar, MD

CONTACT

9196687597; shashank.shekhar@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 13, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)