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

Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: e-Tapper TT-R1

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EH: Stimulation of Head Point; Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1	Device: e-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.
Active Comparator: CS: Control Stimulation; Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1	Device: e-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Karin Schon, Ph.D., Boston University

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; gait; depression; cognition; anxiety; sleep quality; fitness; mood; tremor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: H-34609; BEST-PD2017 (Other Identifier: Boston Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes