Focused Ultrasound + Virtual Reality for Visual Field Loss After Stroke

(LIFU-IVR Trial)

Overseen By Shashank Shekhar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Severe dementia, Seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new therapy can help people who lost some vision after a stroke. It uses low-intensity focused ultrasound, a gentle sound wave, to activate the brain, combined with virtual reality exercises. The goal is to determine if this combination can improve vision problems. Participants should have experienced a stroke 6 to 24 months ago and have difficulty seeing on one side. As an unphased trial, this study offers a unique opportunity to explore an innovative approach to vision recovery.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that low-intensity focused ultrasound stimulation combined with immersive virtual reality is safe for visual field loss after stroke?

Research has shown that low-intensity focused ultrasound (LIFUS) is generally safe for stimulating certain parts of the brain, affecting these areas without causing major problems. Studies have explored LIFUS for various brain conditions, and most people tolerate it well. Some might experience mild discomfort, but serious side effects are rare.

Research indicates that virtual reality is usually safe. People have used virtual reality in many situations, and it is generally well-received. Some may feel dizzy or slightly off-balance, but these effects are typically mild and temporary.

Overall, both LIFUS and virtual reality have been tested separately and appear safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of low-intensity focused ultrasound (LIFUS) with immersive virtual reality (IVR) for visual field loss after stroke because it offers a unique approach compared to traditional treatments like vision therapy and optical aids. Unlike these typical methods, LIFUS uses sound waves to stimulate brain areas, potentially enhancing neural plasticity and recovery. Additionally, when paired with IVR, this technique creates an engaging, immersive environment that could further boost visual rehabilitation by making it more interactive and effective. This innovative blend of technology aims to directly target and improve brain function, offering hope for better recovery outcomes.

What evidence suggests that this trial's treatments could be effective for visual field loss after stroke?

This trial will evaluate the combination of low-intensity focused ultrasound stimulation (LIFUS) and immersive virtual reality (IVR) for improving vision problems after a stroke. Research has shown that LIFUS might enhance vision in stroke patients by targeting specific brain areas, supporting the brain's healing and adaptation. Immersive virtual reality has also shown promise in stroke recovery, aiding patients in improving physical abilities and daily activities. A review found that IVR can positively impact visual recovery in stroke patients. Participants in this trial will be randomized to receive either active LIFUS combined with IVR or inactive LIFUS with IVR to assess the effectiveness of this combination. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke between 6 and 24 months ago and are now experiencing visual field impairments like hemianopia or quadrantanopia. Participants must undergo brain imaging before the therapy.

Inclusion Criteria

I had a stroke between 6 to 24 months ago, confirmed by a scan.

I have partial or complete vision loss in half of my visual field.

Exclusion Criteria

Inability to get a new MRI

Concerns about the inability to complete study visits/procedures by the PI.

I don't have metal implants, scalp wounds, or am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Intervention

Participants are randomized into either the active or sham group and undergo the first intervention session

1 day

1 visit (in-person)

Treatment

Participants undergo 9 sessions of either active or sham LIFUS combined with VR therapy over 21 days

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for changes in visual field, quality of life, and hemodynamic response

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immersive virtual reality
• Low-intensity focused ultrasound

Trial Overview The study tests if low-intensity focused ultrasound stimulation (LIFUS), combined with immersive virtual reality, can improve vision in stroke patients. Brain activity will be measured before and after the treatment to assess its effectiveness.

How Is the Trial Designed?

Group I: LIFUS with IVR Experimental Treatment 2 Interventions

Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy.

Group II: Inactive LIFUS with IVR Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9535681/

The effectiveness of immersive virtual reality in physical ... The results from this review support the potential beneficial effect of fully immersive virtual reality in the rehabilitation of stroke patients ...

2. resna.org resna.org/sites/default/files/conference/2025/EmergingTechnology/Scientific%20Paper%2052-%20Technology_Interveitions_Visual_Stroke.pdf

Effectiveness of technology-based interventions on visual ... About 65% of individuals who had a stroke also experienced changes in their vision, including, but not limited to, homonymous hemianopia, quadrantanopia, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2324242624000421

Virtual reality as a non-conventional rehabilitation for stroke Our findings show that VR based rehabilitations can be beneficial in restoring post-stroke upper limb functions and improving routine life of survivors.

4. frontiersin.org frontiersin.org/journals/systems-neuroscience/articles/10.3389/fnsys.2022.880447/full

The effectiveness of immersive virtual reality in physical ... This study aims to investigate the effectiveness of a fully immersive rehabilitation program using a commercially available head-mounted display in stroke ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109502/

Digital therapeutics using virtual reality‐based visual ... The current trial suggests that VPL‐based digital therapeutics may induce clinically meaningful visual improvements in patients with poststroke VFDs.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39687429/

a single-arm feasibility and proof-of-concept trial This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024005340

A telerehabilitation program to improve visual perception in ... This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05065268

Study Details | NCT05065268 | Visual Rehabilitation in ... Feasibility and effectiveness of a home based audiovisual stimuaton in immersive virtual-reality to restore visual perception in children with brain tumour ...

9. liebertpub.com liebertpub.com/doi/10.1089/jmxr.2024.0007

Reporting on the Acceptance and Usability of a Virtual ... Visual impairment includes decreased visual acuity and contrast sensitivity, color vision loss, and visual field loss, which are often ...

10. formative.jmir.org formative.jmir.org/2025/1/e69801

Safety Evaluation in Healthy Adults of Motion-Based Virtual ... This study investigated the safety of our motion-based virtual reality (VR) dichoptic training app using Japanese Kendama in healthy adult participants.