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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Immersive virtual reality, Low-intensity focused ultrasound for visual field loss after stroke?

The research suggests that the brain can reorganize itself after a stroke, which is important for recovery of vision. This reorganization, or brain plasticity, indicates that treatments like immersive virtual reality and focused ultrasound might help improve visual field loss by encouraging the brain to adapt and compensate for the damage. ^{1 2 3 4 5}

How does the treatment of Low-intensity focused ultrasound combined with Virtual Reality differ from other treatments for visual field loss after stroke?

This treatment is unique because it combines low-intensity focused ultrasound, which uses sound waves to stimulate brain areas, with virtual reality to potentially enhance visual rehabilitation. Unlike traditional methods that focus solely on visual exercises or medications, this approach aims to directly influence brain plasticity and reorganization, offering a novel way to address visual field loss after stroke. ^{2 5 6 7 8}

Eligibility Criteria

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

I do not have a history of major eye problems like blindness or severe vision loss.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Adaptation to post-stroke homonymous hemianopia - a prospective longitudinal cohort study to identify predictive factors of the adaptation process. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnosis and rehabilitation of visual field defects in stroke patients: a retrospective audit. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prism therapy and visual rehabilitation in homonymous visual field loss. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A study on the natural history of scanning behaviour in patients with visual field defects after stroke. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Extrastriate visual cortex reorganizes despite sequential bilateral occipital stroke: implications for vision recovery. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Linking Multi-Modal MRI to Clinical Measures of Visual Field Loss After Stroke. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sectoral Differences in the Association of Optic Nerve Head Blood Flow and Glaucomatous Visual Field Defect Severity and Progression. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Acquired Visual Deficits Independent of Lesion Site in Acute Stroke. [2020]