Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Visuospatial Cognition
研究概览
简要总结
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction and non-motor symptoms. Here, the investigators propose in a pilot device feasibility trial to examine whether "Bio Electro Stimulation Therapy" (B.E.S.T.) with a small, non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hand can ameliorate some of the symptoms of PD.
详细描述
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction, cognitive impairment, and other non-motor symptoms. Here, we propose to use "Bio Electro Stimulation Therapy" (B.E.S.T.) using the "e-Tapper TT-R1"owned by Immumax International Co. Ltd., a Hong Kong based company. The "e-Tapper" is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hand at specified points representing various body parts, such as the head, leg, or foot. This is one form of Bio Electro Stimulation Therapy, known as "11-point Hand Treatment System". The current delivered is less than one milliampere. Anecdotal evidence suggests that this micro current stimulation may reduce resting tremor, restore facial expressions, and improve ease of movement, mood, and sleep quality in patients with PD. Scientific evidence for the effectiveness of the B.E.S.T. Hand Therapy appears to be lacking in the English language (Western) literature. The goal of this pilot device feasibility study is to examine whether B.E.S.T. can increase physical activity and functional fitness, enhance cognition, improve mood and subjective sleep quality, and modulate resting tremor and gait parameters in PD patients over a 6-week period.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High functioning without presence of cognitive impairment or dementia
- •Native-English speaker or fluent in English
- •Diagnosis of Parkinson's disease (Hoehn & Yahr stages I-III)
排除标准
- •Implanted medical devices, such as a pacemaker or defibrillator
- •Prescription medication or other drugs that affect the brain (e.g. anti-depressants, anxiolytics), except prescription medication for the treatment of Parkinson's disease
- •Poor vision that cannot be corrected with glasses or contact lenses
- •Presence of musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain)
- •Not being able to walk without assistance
- •Diagnosis of dementia or mild cognitive impairment
- •Diabetes mellitus
- •Taking medications for diabetes mellitus
- •Skin irritation, disease or wound on the hands
- •Current heart conditions, such as congestive heart failure, tachycardia, or other arrhythmias
- •History of heart attack
- •Psychiatric or neurological disorders other than Parkinson's disease (e.g. Major Depressive Disorder, anxiety disorder, epilepsy)
结局指标
主要结局
Visuospatial Cognition
时间窗: 10-12 weeks
Assessment of visuospatial cognition
Resting tremor
时间窗: 10-12 weeks
Resting tremor will be assessed with body-worn sensors.
Gait
时间窗: 10-12 weeks
Gait will be assessed with body-worn sensors.
Physical activity
时间窗: 10-12 weeks
Assessment of physical activity with body-worn sensor
Mood
时间窗: 10-12 weeks
Mood will be assessed with questionnaires.
Sleep quality
时间窗: 10-12 weeks
Sleep quality will be assessed with a questionnaire.
次要结局
- Perceived pain(10-12 weeks)
- Quality of life and subjective health status(10-12 weeks)
- Physical activity - Other(10-12 weeks)
- Cognition - Language(10-12 weeks)
- Cognition - Cognitive Control(10-12 weeks)
- Functional Fitness(10-12 weeks)
- Cognition - learning and memory(10-12 weeks)
研究者
Karin Schon
Assistant Professor, Anatomy & Neurobiology
Boston University