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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Visual Field Defect; Visual Field Defect Following Cerebrovascular Accident; Hemianopia; Quadrantanopia; Occipital Lobe Infarct; Visual Fields Hemianopsia

• Registration Number: NCT06875206
• Lead Sponsor: Duke University

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 (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.

Study Timeline

• Study First Submitted: 2025-02-11
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Start: 2025-04
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Field Change	From enrollment to the 30 days after the end of treatment.	Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset

Secondary Outcome Measures

Name	Time	Method
Quality of Life Change	From enrollment to the 30 days after the end of treatment.	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	From enrollment to the 30 days after the end of treatment.	Change in oxygenated hemoglobin concentration or blood-oxygen-level-dependent (BOLD) signal response from baseline and after intervention

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States