Bio Electro Stimulation Therapy for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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-R1owned 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.

Official Title
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Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: e-Tapper TT-R1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EH: Stimulation of Head Point<br>Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1 | Device: e-Tapper TT-R1<br>* The e-Tapper is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hands 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 the 11-point Hand Treatment System. The current delivered is less than one milliampere.<br>|
| Active Comparator: CS: Control Stimulation<br>Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1 | Device: e-Tapper TT-R1<br>* The e-Tapper is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hands 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 the 11-point Hand Treatment System. The current delivered is less than one milliampere.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Assessment of physical activity with body-worn sensor | 10-12 weeks | 
| Visuospatial Cognition | Assessment of visuospatial cognition | 10-12 weeks | 
| Mood | Mood will be assessed with questionnaires. | 10-12 weeks | 
| Sleep quality | Sleep quality will be assessed with a questionnaire. | 10-12 weeks | 
| Resting tremor | Resting tremor will be assessed with body-worn sensors. | 10-12 weeks | 
| Gait | Gait will be assessed with body-worn sensors. | 10-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain | Perceived pain will be assessed with a questionnaire. | 10-12 weeks | 
| Quality of life and subjective health status | This questionnaire, called The 39-Item Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's disease experience difficulties in their lives in several domains, including mobility, activities of daily living, emotional well-being, stigma, social support, perceived cognition, communication, and bodily discomfort. A PDQ-39 Summary Index score will be calculated. Scores range from 0 (best quality of life) to 100 (worst quality of life). | 10-12 weeks | 
| Physical activity - Other | Subjective physical activity will be assessed with a questionnaire. | 10-12 weeks | 
| Functional Fitness | Participants will undergo short field tests of functional fitness. | 10-12 weeks | 
| Cognition - Language | Assessment of verbal fluency | 10-12 weeks | 
| Cognition - Cognitive Control | Assessment of executive functions | 10-12 weeks | 
| Cognition - learning and memory | Assessment of learning and memory | 10-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fitness, physical activity, cognition, mood, depression, anxiety, sleep quality, tremor, gait