Bio Electro Stimulation Therapy for Parkinson's Disease

NCT ID: NCT03014050

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2019-06-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EH: Stimulation of Head Point

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

Group Type: EXPERIMENTAL

e-Tapper TT-R1

Intervention Type: 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.

CS: Control Stimulation

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

Group Type: ACTIVE_COMPARATOR

e-Tapper TT-R1

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Karin Schon

Assistant Professor, Anatomy & Neurobiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Schon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

BEST-PD2017

Identifier Type: OTHER

Identifier Source: secondary_id

H-34609

Identifier Type: -

Identifier Source: org_study_id