Status:
NOT_YET_RECRUITING
Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
Lead Sponsor:
Duke University
Conditions:
Stroke
Visual Field Defect
Eligibility:
All Genders
18+ years
Phase:
NA
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 (LIFU...
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 b...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06875206
Start Date
December 1 2025
End Date
April 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710