Bio Electro Stimulation Therapy for Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: e-Tapper TT-R1
- Registration Number
- NCT03014050
- Lead Sponsor
- Boston University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CS: Control Stimulation e-Tapper TT-R1 Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1 EH: Stimulation of Head Point e-Tapper TT-R1 Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1
- Primary Outcome Measures
Name Time Method Visuospatial Cognition 10-12 weeks Assessment of visuospatial cognition
Resting tremor 10-12 weeks Resting tremor will be assessed with body-worn sensors.
Gait 10-12 weeks Gait will be assessed with body-worn sensors.
Physical activity 10-12 weeks Assessment of physical activity with body-worn sensor
Mood 10-12 weeks Mood will be assessed with questionnaires.
Sleep quality 10-12 weeks Sleep quality will be assessed with a questionnaire.
- Secondary Outcome Measures
Name Time Method Perceived pain 10-12 weeks Perceived pain will be assessed with a questionnaire.
Quality of life and subjective health status 10-12 weeks 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).
Physical activity - Other 10-12 weeks Subjective physical activity will be assessed with a questionnaire.
Cognition - Language 10-12 weeks Assessment of verbal fluency
Cognition - Cognitive Control 10-12 weeks Assessment of executive functions
Functional Fitness 10-12 weeks Participants will undergo short field tests of functional fitness.
Cognition - learning and memory 10-12 weeks Assessment of learning and memory
Trial Locations
- Locations (1)
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States