An interventional study of Low-intensity focused ultrasound and Immersive virtual reality in Stroke, Visual Field Defect and Visual Field Defect Following Cerebrovascular Accident, sponsored by Duke University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 28 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy.
Device: Low-intensity focused ultrasound · Device: Immersive virtual reality
The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy
Device: Immersive virtual reality · Device: Inactive 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.
Also known as: LIFU
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.
Also known as: IVR
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.
Visual Field Change
Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset
Time frame: From enrollment to the 30 days after the end of treatment.
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)
Time frame: From enrollment to the 30 days after the end of treatment.
Hemodynamic response change
Change in oxygenated hemoglobin concentration or blood-oxygen-level-dependent (BOLD) signal response from baseline and after intervention
Time frame: From enrollment to the 30 days after the end of treatment.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 19 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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