Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Visual Field Change
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Immersive virtual reality (Device)
Inactive LIFUS with IVR
The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy
干预措施: Immersive virtual reality (Device)
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.
干预措施: Low-intensity focused ultrasound (Device)
Inactive LIFUS with IVR
The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy
干预措施: Inactive Low-intensity focused ultrasound (Device)
结局指标
主要结局
Visual Field Change
时间窗: 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
次要结局
- Quality of Life Change(From enrollment to the 30 days after the end of treatment.)
- Hemodynamic response change(From enrollment to the 30 days after the end of treatment.)