StableEyes With Active Neurophysiological Feedback
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Change in Motion sickness intensity as assessed by subjective rating
研究概览
简要总结
The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.
详细描述
The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.
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
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma
- •Willing to adhere to the SWAN and/or vestibular rehabilitation regimen
排除标准
- •Current use of anti-nausea medication
- •Presence of cervical spine pathology that limits head motion to < 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)
- •Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery)
- •Legal blindness (20/200 or worse visual acuity)
- •Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days
研究组 & 干预措施
SWAN VPT JHU
Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method
干预措施: SWAN (Device)
SWAN Motion Sick Dayton
Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.
干预措施: SWAN (Device)
Traditional Motion Sick Dayton
Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment.
Traditional Vestibular Physical Therapy (VPT) JHU
Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.
干预措施: Traditional Therapy (Behavioral)
结局指标
主要结局
Change in Motion sickness intensity as assessed by subjective rating
时间窗: Daily for up to 4 weeks
Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting.
次要结局
- Change in Rod and Frame Test(Daily for up to 4 weeks)
- Change in Timed Up and Go Plus(Daily for up to 4 weeks)
- Change in Foam Stance - Eyes Open with head motion(Daily for up to 4 weeks)
- Change in Foam Stance - Eyes Closed with head motion(Daily for up to 4 weeks)
- Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography(Daily for up to 4 weeks)
- Change in Foam Stance - Eyes Closed(Daily for up to 4 weeks)
- Change in Number of blinks as measured by video-oculography(Daily for up to 4 weeks)
- Change in Heart rate as measured by a monitor worn over the forearm(Daily for up to 4 weeks)
- Change in Foam Stance - Eyes Open(Daily for up to 4 weeks)
- Change in Gait speed(Daily for up to 4 weeks)
- Change in Gait endurance(Daily for up to 4 weeks)
- Change in Rod and Disk Test(Daily for up to 4 weeks)
- Change in Vertical and torsional alignment nulling test (VAN and TAN)(Daily for up to 4 weeks)
- Change in Daily Activity as assessed by an activity monitor(Daily for up to 4 weeks)
- Change in Subjective Visual Vertical(Daily for up to 4 weeks)