Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Freezing of Gait
研究概览
简要总结
This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.
详细描述
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4
排除标准
- •History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
- •Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
- •Evidence of a stroke or mass lesion on structural brain imaging (MRI).
- •Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- •Severe claustrophobia precluding MR or PET imaging.
- •Subjects limited by participation in research procedures involving ionizing radiation.
- •Pregnancy (test within 48 hours of each PET session) or breastfeeding.
- •Subjects with active and unstable mood or anxiety disorders
- •Subjects with active ear infections or perforated eardrums
研究组 & 干预措施
Investigational Treatment 1
Investigational treatment stimulation pattern 1
干预措施: Non invasive neuromodulation device pattern 1 (Device)
Investigational Treatment 2
Investigational treatment stimulation pattern 2
干预措施: Non invasive neuromodulation device pattern 2 (Device)
结局指标
主要结局
Freezing of Gait
时间窗: after a week of treatment
Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait
次要结局
未报告次要终点
研究者
Chatkaew Pongmala
Research Investigator
University of Michigan