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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
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.
Boston University School of Medicine
Boston, Massachusetts, United States
Physical activity
Assessment of physical activity with body-worn sensor
Time frame: 10-12 weeks
Visuospatial Cognition
Assessment of visuospatial cognition
Time frame: 10-12 weeks
Mood
Mood will be assessed with questionnaires.
Time frame: 10-12 weeks
Sleep quality
Sleep quality will be assessed with a questionnaire.
Time frame: 10-12 weeks
Resting tremor
Resting tremor will be assessed with body-worn sensors.
Time frame: 10-12 weeks
Gait
Gait will be assessed with body-worn sensors.
Time frame: 10-12 weeks
Perceived pain
Perceived pain will be assessed with a questionnaire.
Time frame: 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).
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Time frame: 10-12 weeks
Physical activity - Other
Subjective physical activity will be assessed with a questionnaire.
Time frame: 10-12 weeks
Functional Fitness
Participants will undergo short field tests of functional fitness.
Time frame: 10-12 weeks
Cognition - Language
Assessment of verbal fluency
Time frame: 10-12 weeks
Cognition - Cognitive Control
Assessment of executive functions
Time frame: 10-12 weeks
Cognition - learning and memory
Assessment of learning and memory
Time frame: 10-12 weeks