Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline gait cycle at one day post intervention
研究概览
简要总结
This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.
详细描述
Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- •Hoehn and Yahr stage ≤ 2 during ON medication state.
- •Age between 40 and 80 years old.
- •Mini-Mental State Examination score >
- •Ability to walk at least 60s independently.
- •Stable medication
排除标准
- •Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study.
- •Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded
- •Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.
结局指标
主要结局
Change from Baseline gait cycle at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
The gait cycle will be recorded in s.
Changes in Tinetti Gait scores at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
This indicator mainly reflects the stability of posture .
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms.
Change from Baseline arm ROM maximum at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
The arm ROM maximum will be recorded in degree.
Changes in Tinetti Balance scores at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
This indicator mainly reflects the stability of gait.
Change from Baseline Velocity at one day post intervention
时间窗: Assessed at baseline, one day post intervention
The velocity will be recorded in cm/s.
Change from Baseline turning average duration velocity at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
The turning average duration velocity will be recorded in cm/s.
Change from Baseline Step length at one day post intervention
时间窗: Assessed at baseline, one day post intervention.
The step length will be recorded in meters.
次要结局
- Changes in ΔHbO2 concentration in the brain cortex(Assessed at baseline, one day post intervention.)
研究者
Kezhong Zhang
professor，Chief physician
The First Affiliated Hospital with Nanjing Medical University