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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06875206
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-intensity focused ultrasound — DEVICE
    Low-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 — DEVICE
    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.
  • Inactive Low-intensity focused ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LIFUS with IVR
    Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy.
  • Sham Comparator: Inactive LIFUS with IVR
    The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy

Primary Outcome Measure

Visual Field Change [ Time Frame: From enrollment to the 30 days after the end of treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Duke University Health System· Durham, NC

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