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| ID | Type | Description | Link |
|---|---|---|---|
| BEST-PD2017 | Other Identifier | Boston Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EH: Stimulation of Head Point | Experimental | Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1 |
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| CS: Control Stimulation | Active Comparator | Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-Tapper TT-R1 | Device | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Schon, Ph.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |