About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Low-intensity focused ultrasound
DeviceLow-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain.
Immersive virtual reality
DeviceIVR 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.
Inactive Low-intensity focused ultrasound
DeviceHigh 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.
Treatment groups
Trial outcomes
Primary outcomes
Visual Field Change
Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset
Secondary outcomes
Quality of Life Change
Change as assessed by the National Eye Institute 25 Item Visual Function Questionnaire (NEI-VFQ 25). The NEI-VFQ is a vision based questionnaire which evaluates quality of life with respect to vision in everyday life. The NEI-VFQ has multiple sub-scales for different areas of life, such as Near-Vision, General Health, or Ocular Pain. Each scale is scored from 0 to 100 with 100 representing the best possible score (perfect health or ability)
Hemodynamic response change
Change in oxygenated hemoglobin concentration or blood-oxygen-level-dependent (BOLD) signal response from baseline and after intervention
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: