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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
e-Tapper TT-R1
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring physical activity, fitness, cognition, mood, depression, anxiety, sleep quality, tremor, gait

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EH: Stimulation of Head Point

CS: Control Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Physical activity
Assessment of physical activity with body-worn sensor
Visuospatial Cognition
Assessment of visuospatial cognition
Mood
Mood will be assessed with questionnaires.
Sleep quality
Sleep quality will be assessed with a questionnaire.
Resting tremor
Resting tremor will be assessed with body-worn sensors.
Gait
Gait will be assessed with body-worn sensors.

Secondary Outcome Measures

Perceived pain
Perceived pain will be assessed with a questionnaire.
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).
Physical activity - Other
Subjective physical activity will be assessed with a questionnaire.
Functional Fitness
Participants will undergo short field tests of functional fitness.
Cognition - Language
Assessment of verbal fluency
Cognition - Cognitive Control
Assessment of executive functions
Cognition - learning and memory
Assessment of learning and memory

Full Information

First Posted
December 12, 2016
Last Updated
April 1, 2020
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03014050
Brief Title
Bio Electro Stimulation Therapy for Parkinson's Disease
Acronym
BEST
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
physical activity, fitness, cognition, mood, depression, anxiety, sleep quality, tremor, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EH: Stimulation of Head Point
Arm Type
Experimental
Arm Description
Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1
Arm Title
CS: Control Stimulation
Arm Type
Active Comparator
Arm Description
Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1
Intervention Type
Device
Intervention Name(s)
e-Tapper TT-R1
Intervention Description
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 Measure Information:
Title
Physical activity
Description
Assessment of physical activity with body-worn sensor
Time Frame
10-12 weeks
Title
Visuospatial Cognition
Description
Assessment of visuospatial cognition
Time Frame
10-12 weeks
Title
Mood
Description
Mood will be assessed with questionnaires.
Time Frame
10-12 weeks
Title
Sleep quality
Description
Sleep quality will be assessed with a questionnaire.
Time Frame
10-12 weeks
Title
Resting tremor
Description
Resting tremor will be assessed with body-worn sensors.
Time Frame
10-12 weeks
Title
Gait
Description
Gait will be assessed with body-worn sensors.
Time Frame
10-12 weeks
Secondary Outcome Measure Information:
Title
Perceived pain
Description
Perceived pain will be assessed with a questionnaire.
Time Frame
10-12 weeks
Title
Quality of life and subjective health status
Description
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).
Time Frame
10-12 weeks
Title
Physical activity - Other
Description
Subjective physical activity will be assessed with a questionnaire.
Time Frame
10-12 weeks
Title
Functional Fitness
Description
Participants will undergo short field tests of functional fitness.
Time Frame
10-12 weeks
Title
Cognition - Language
Description
Assessment of verbal fluency
Time Frame
10-12 weeks
Title
Cognition - Cognitive Control
Description
Assessment of executive functions
Time Frame
10-12 weeks
Title
Cognition - learning and memory
Description
Assessment of learning and memory
Time Frame
10-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Schon, Ph.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Bio Electro Stimulation Therapy for Parkinson's Disease

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