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Completed

NCT Number: NCT03014050

Bio Electro Stimulation Therapy for Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Anxiety Disorders Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Dyskinesias Dyssomnias Mental Disorders Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Synucleinopathies Tremor

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

e-Tapper TT-R1

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.

Primary outcomes

  1. Physical activity

    Time frame: 10-12 weeks

    Assessment of physical activity with body-worn sensor

  2. Visuospatial Cognition

    Time frame: 10-12 weeks

    Assessment of visuospatial cognition

  3. Mood

    Time frame: 10-12 weeks

    Mood will be assessed with questionnaires.

  4. Sleep quality

    Time frame: 10-12 weeks

    Sleep quality will be assessed with a questionnaire.

  5. Resting tremor

    Time frame: 10-12 weeks

    Resting tremor will be assessed with body-worn sensors.

  6. Gait

    Time frame: 10-12 weeks

    Gait will be assessed with body-worn sensors.

Secondary outcomes

  1. Perceived pain

    Time frame: 10-12 weeks

    Perceived pain will be assessed with a questionnaire.

  2. Quality of life and subjective health status

    Time frame: 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).

  3. Physical activity - Other

    Time frame: 10-12 weeks

    Subjective physical activity will be assessed with a questionnaire.

  4. Functional Fitness

    Time frame: 10-12 weeks

    Participants will undergo short field tests of functional fitness.

  5. Cognition - Language

    Time frame: 10-12 weeks

    Assessment of verbal fluency

  6. Cognition - Cognitive Control

    Time frame: 10-12 weeks

    Assessment of executive functions

  7. Cognition - learning and memory

    Time frame: 10-12 weeks

    Assessment of learning and memory

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

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

Acronym: BEST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2017
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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