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

Launched by DUKE UNIVERSITY · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment to help improve vision for people who have had a stroke and are experiencing vision problems, such as difficulty seeing to one side (a condition called hemianopia). The study combines a technique called low-intensity focused ultrasound stimulation (LIFUS), which uses sound waves to stimulate specific areas of the brain related to vision, with virtual reality therapy. Participants will undergo brain imaging before starting the treatment and again after the study to see how their brain responds to the therapy.

To be eligible for the study, participants must be at least 18 years old, have had an ischemic (blocked blood flow) or hemorrhagic (bleeding) stroke 6 to 24 months ago, and show signs of vision impairment. During the 1.5 months of active participation, individuals will receive the treatment and take part in assessments to monitor their progress. It's important to note that people with certain medical conditions, such as severe dementia or a history of seizures, or those with specific implants or injuries, may not be able to join the study. This research aims to find out if this innovative approach can help restore some vision for stroke survivors.

Gender

ALL

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.