Bio Electro Stimulation Therapy for Parkinson's Disease (BEST)

Boston University

Status and phase: Completed; Early Phase 1

Conditions: Parkinson Disease

Treatments: Device: e-Tapper TT-R1

Study type: Interventional

Funder types: Other

Identifiers

NCT03014050

H-34609

BEST-PD2017 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

EH: Stimulation of Head Point

Experimental group

Description:

Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1

Treatment:

Device: e-Tapper TT-R1

CS: Control Stimulation

Active Comparator group

Description:

Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1

Treatment:

Device: e-Tapper TT-R1