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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014050
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Karin Schon, Boston University

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: e-Tapper TT-R1 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014050


Locations
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United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Karin Schon, Ph.D. Boston University
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Responsible Party: Karin Schon, Assistant Professor, Anatomy & Neurobiology, Boston University
ClinicalTrials.gov Identifier: NCT03014050    
Other Study ID Numbers: H-34609
BEST-PD2017 ( Other Identifier: Boston Medical Center )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Karin Schon, Boston University:
physical activity
fitness
cognition
mood
depression
anxiety
sleep quality
tremor
gait
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases