Clinical trial NCT03014050: Bio Electro Stimulation Therapy for Parkinson's Disease
Official title: Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Keywords: physical activity
fitness
cognition
mood
depression
anxiety
sleep quality
tremor
gait
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical activity
timeFrame: 10-12 weeks
measure: Visuospatial Cognition
timeFrame: 10-12 weeks
measure: Mood
timeFrame: 10-12 weeks
measure: Sleep quality
timeFrame: 10-12 weeks
measure: Resting tremor
timeFrame: 10-12 weeks
measure: Gait
timeFrame: 10-12 weeks
Secondary outcomes:
measure: Perceived pain
timeFrame: 10-12 weeks
measure: Quality of life and subjective health status
timeFrame: 10-12 weeks
measure: Physical activity - Other
timeFrame: 10-12 weeks
measure: Functional Fitness
timeFrame: 10-12 weeks
measure: Cognition - Language
timeFrame: 10-12 weeks
measure: Cognition - Cognitive Control
timeFrame: 10-12 weeks
measure: Cognition - learning and memory
timeFrame: 10-12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Karin Schon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: