Parkinson Disease
Conditions
Keywords
physical activity, fitness, cognition, mood, depression, anxiety, sleep quality, tremor, gait
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-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.
Interventions
DEVICEe-Tapper TT-R1
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.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 10-12 weeks | Assessment of physical activity with body-worn sensor |
| Visuospatial Cognition | 10-12 weeks | Assessment of visuospatial cognition |
| Mood | 10-12 weeks | Mood will be assessed with questionnaires. |
| Sleep quality | 10-12 weeks | Sleep quality will be assessed with a questionnaire. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognition - learning and memory | 10-12 weeks | Assessment of learning and memory |
| Cognition - Cognitive Control | 10-12 weeks | Assessment of executive functions |
| 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. |
| Functional Fitness | 10-12 weeks | Participants will undergo short field tests of functional fitness. |
| Cognition - Language | 10-12 weeks | Assessment of verbal fluency |
Countries
United States
Outcome results
None listed