Caloric Vestibular Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)
研究概览
简要总结
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.
详细描述
Parkinson's Disease (PD) is a nationwide public health problem, inflicting a complex constellation of physical and neuropsychiatric symptoms which are shown to progress with time. This research will investigate the potential of caloric vestibular stimulation (CVS), a non-invasive form of brain stimulation, as a treatment for individuals who suffer from Parkinson's Disease. Investigators will investigate whether core cognitive and physiological deficits are responsive to stimulation by comparing participants' performance on behavioral and physiological measures after baseline and either active or placebo stimulation phases with the aim of drawing initial insights into the application of CVS within this population. The study design is based on a single-case study that recently demonstrated durable, clinically meaningful gains in the motor and nonmotor symptoms of PD.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be diagnosed with idiopathic Parkinson's Disease as defined by the UK PDS Brain Bank Criteria.
- •Participants must report limitations to Activities of Daily Life (ADL, UPDRS subscale 2)
- •Capacity to consent to the study
- •Motivated to comply with the protocol
- •An understanding of English sufficient to comply with the protocol
- •Spouse/ carer willing to support the participant throughout the study
排除标准
- •Diagnosis of induced Parkinson's or essential/dystonic tremor
- •Premorbid psychiatric history (including affective disorder, psychosis or deliberate self- harm)
- •Previous exposure to neurostimulation
- •Inner ear pathology
结局指标
主要结局
Change From Baseline in the Nonmotor Symptom Severity Scale (NMSS)
时间窗: Change at end of treatment (week 12) relative to the average of two baseline visits
The NMSS is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. Score range of 0-360, with 0 being no symptom burden
次要结局
- Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III: Motor Examination(Change at end of treatment (week 12) relative to baseline average)
- Change From Baseline in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Motor Aspects of Experiences of Daily Living(Change at end of treatment (week 12) relative to baseline average)