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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

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 volunteers

Qualifiers

≥ 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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: LIFUS with IVRExperimental treatment 2 interventions
Group B: Inactive LIFUS with IVRSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

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