Electrical Vestibular Neve Stimulation(VeNS) in the Management of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Unified Parkinson's disease Rating Scale (UPDRS)
研究概览
简要总结
Parkinson's disease burdens an increasing number of elderly populations in the country.
Parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately
1% of the population by the age of 65 years and 4% to 5% of the population by the age of 85 years. Mild cognitive impairment in Parkinson's disease leads to Parkinson's disease dementia (PDD) for which currently there is no drug therapy. The existing treatments for PD were associated with side effects and does not offer complete cure. Hence there is a need of alternative therapy which can prevent or delay the onset of PD with less or no side effects. Vestibular stimulation is known to modulate cognitive processing, enhance learning and spatial memory.
Vestibular dysfunction is present in PD patients. So long term vestibular stimulation may be effective in enhancing cognition by reducing the cognitive, neurodegenerative, neuroinflammatory changes and behavioral deficits observed as predictors of Mild Cognitive Impairment in Parkinson's disease Dementia. In this project, the plan is to administer electric vestibular nerve stimulation to PD patients which might be effective and ideal treatment with minimum or no side effects in the management of Parkinson's disease.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Fulfilled the Hoehn & Yahr Classification of Disability 79,80 stage 1-2
- •Ambulate with or without an assistive device for at least 50 feet
- •Were able to get up and down from the floor with minimal assistance or less and
- •Score of 24 or above on the Folstein Mini-Mental State Exam
排除标准
- •Decline in immune function such as pneumonia or systemic infection
- •Progressive degenerative disease besides PD
- •Spinal fusion or other orthopedic surgery in the past six months
- •Mental disease/psychosis such as dementia
- •Greater than minimal assistance required for gait and transfers
- •Inability to make regular time commitments to the scheduled intervention sessions
- •Experience with regular practice of any form of vestibular stimulation within the past year
结局指标
主要结局
Unified Parkinson's disease Rating Scale (UPDRS)
时间窗: 12 weeks
The UPDRS has been the most used Parkinsons disease scale. It is a 42 item questionnaire grouped into four subscales. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
次要结局
- Berg Balance Scale (BBS)(12 weeks)
- Muscle Strength(12 weeks)
- Estimation of dopamine(12 weeks)
- Flexibility(12 weeks)
- Assessment of verbal memory(12 weeks)
- Assessment of quality of life(12 weeks)
- Assessment of radiological images(12 weeks)
- Range of motion (ROM)(12 weeks)
- Assessment of neuronal loss(12 weeks)
- Assessment of hand-eye coordination(12 weeks)
- Auditory and visual reaction time(12 weeks)
- Estimation of Gamma-Aminobutyric Acid (GABA)(12 weeks)
- Assessment of spatial memory(12 weeks)