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临床试验/NCT04768647
NCT04768647已完成1 期

Vestibulopathy, Imbalance and Gait Disturbances in Parkinson Disease

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月28日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
3
主要终点
Vestibular function

研究概览

简要总结

Balance problems and falls are common in people with Parkinson's disease but respond poorly to dopamine stimulating medications suggesting other causes. The main goal of this study is to assess whether imbalance and gait problems in people with Parkinson's disease may be related to vestibular (inner ear balance center) changes not related to loss of dopamine in the brain.

详细描述

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, slowness of movement, rigidity as well as postural instability and gait difficulties (PIGD) motor features. Nigrostriatal dopaminergic denervation is a key pathological factor in PD. Advancing PD is associated with disabling PIGD motor features, in particular freezing of gait (FoG). This is further complicated by fear of falling resulting in pervasive sedentariness where avoidance of physical activity leads to deconditioning, thereby aggravating a downward functional spiral. The dopaminergic medication-refractory nature of PIGD motor features in advancing PD implicates non-dopaminergic brain pathologies.

The investigators have novel preliminary data showing that non-acute vestibulopathy may be another important factor contributing to PIGD motor features in PD. Unlike sporadic intermittent vestibular disorders with a more acute onset, chronic bilateral vestibular dysfunction of older age. The investigators preliminary data suggest that vestibulopathy may be a critical determinant of imbalance and gait problems in PD (scientific premise). However, these preliminary observations need to be confirmed in a larger study using more dedicated assessment methods (knowledge gap). Closing this gap is important because of the potentially high clinical translational impact if preliminary findings can be verified. The investigators will also explore whether stimulation of the vestibular system may help to improve PIGD in a small exploratory pilot biomechanistic sub-study.

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 (Investigator, Outcomes Assessor)

盲法说明

Independent assessor

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (n=64, gross recruitment)
  • age 45 years or older
  • duration of disease > 5 years and/or Hoehn & Yahr stages 1.5-4 able to ambulate independently and no evidence of dementia.

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.

研究组 & 干预措施

Main cohort

No Intervention

Main cohort of all patients

Subgroup of patients with imbalance

Sham Comparator

Subgroup of patients with imbalance

干预措施: TNM (Device)

结局指标

主要结局

Vestibular function

时间窗: through study completion, an average of 4 weeks

Assessment of vestibular functions using standard vestibular testing

Imbalance score

时间窗: through study completion, an average of 1 year

Clinical imbalance motor score

次要结局

  • DAT brain PET(through study completion, an average of 1 year)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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