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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIFUS with IVR | Experimental | Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy. |
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| Inactive LIFUS with IVR | Sham Comparator | The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field Change | Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset | From enrollment to the 30 days after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Gonzalez, MSCR | Contact | 919-668-7597 | megan.gonzalez@duke.edu | |
| Shashank Shekhar, MD | Contact | 9196687597 | shashank.shekhar@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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| 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. |
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| 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. |
|
| 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 | From enrollment to the 30 days after the end of treatment. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006423 | Hemianopsia |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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