Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-intensity focused ultrasound, Immersive virtual reality, Inactive Low-intensity focused ultrasound.
- Who it may be relevant to
- Registry conditions: Stroke, Visual Field Defect, Visual Field Defect Following Cerebrovascular Accident, Hemianopia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 below.
* Group 1 (Sham Group): Inactive LIFU + VR * Group 2 (Active Group): LIFU + VR Neither the subject nor the researcher conducting this study will know which group participants are in.
Sham LIFU: The setup is similar for the active stimulation group, except that a high acoustic impedance disk will be placed between the LIFU probe and the scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. The audible sound is nearly identical for both the sham and active stimulation.
Intervention visits (9 sessions over 21 days, about 2.5 hours per visit):
At these visits, participants will undergo the investigational study interventions.
There will be 30 minutes of a VR session and 20 minutes of active LIFU or inactive LIFU treatments.
Interventions
- Device Low-intensity focused ultrasound
Low-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain. - Device Immersive virtual reality
IVR 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. - Device Inactive Low-intensity focused ultrasound
High 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.
Primary outcome measures
- Visual Field Change [Time frame: From enrollment to the 30 days after the end of treatment.]
Secondary outcome measures (2)
- Quality of Life Change [Time frame: From enrollment to the 30 days after the end of treatment.]
- Hemodynamic response change [Time frame: From enrollment to the 30 days after the end of treatment.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Health System — Durham
Identifiers
NCT: NCT06875206 · Pro00115941