Vibrotactile Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Patients Reporting Any Adverse Effects
研究概览
简要总结
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.
详细描述
Patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. This testing includes the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will explain the study and obtain informed consent. There will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following: Patients will have sensors put on their hands, feet, and chest. These sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. During this time, patients will be provided with books/movies as entertainment, and they may move around freely. Patients will also be asked to complete several questionnaires throughout the visits about their Parkinson's symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years of age.
- •Speaks and understands English.
- •A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
- •Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
- •Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
- •Have improvement in motor signs ON versus OFF dopaminergic medication.
- •If on medication, the patient should be on stable doses of Sinemet and/or Stalevo (Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen (Patient does not need to be on medication to be included in the study).
排除标准
- •Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
- •Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
- •Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
- •Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
- •Subjects who have an inability to comply with study follow-up visits.
- •Subjects who are unable to understand or sign the informed consent.
- •Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder.
- •Have an active infection.
- •Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
研究组 & 干预措施
Vibrotactile Stimulation Treatment
All patients will receive the vibrotactile stimulation treatment. No deception will be used.
干预措施: Vibrotactile Stimulation (Device)
结局指标
主要结局
Number of Patients Reporting Any Adverse Effects
时间窗: 1 Month
Questionnaire asks patients to record any adverse effects they experienced.
次要结局
- Unified Parkinson's Disease Rating Scale, Part III(1 Month)
- Root Mean Square Velocity(1 Month)
- Gait Asymmetry(1 Month)
研究者
Helen M. Bronte-Stewart
Principal Investigator
Stanford University