<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014050</url>
  </required_header>
  <id_info>
    <org_study_id>H-34609</org_study_id>
    <secondary_id>BEST-PD2017</secondary_id>
    <nct_id>NCT03014050</nct_id>
  </id_info>
  <brief_title>Bio Electro Stimulation Therapy for Parkinson's Disease</brief_title>
  <acronym>BEST</acronym>
  <official_title>Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction&#xD;
      and non-motor symptoms. Here, the investigators propose in a pilot device feasibility trial&#xD;
      to examine whether &quot;Bio Electro Stimulation Therapy&quot; (B.E.S.T.) with a small, non-invasive,&#xD;
      handheld electronic device designed to apply micro current stimulation to a person's hand can&#xD;
      ameliorate some of the symptoms of PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction,&#xD;
      cognitive impairment, and other non-motor symptoms. Here, we propose to use &quot;Bio Electro&#xD;
      Stimulation Therapy&quot; (B.E.S.T.) using the &quot;e-Tapper TT-R1&quot;owned by Immumax International Co.&#xD;
      Ltd., a Hong Kong based company. The &quot;e-Tapper&quot; is a non-invasive, handheld electronic device&#xD;
      designed to apply micro current stimulation to a person's hand at specified points&#xD;
      representing various body parts, such as the head, leg, or foot. This is one form of Bio&#xD;
      Electro Stimulation Therapy, known as &quot;11-point Hand Treatment System&quot;. The current delivered&#xD;
      is less than one milliampere. Anecdotal evidence suggests that this micro current stimulation&#xD;
      may reduce resting tremor, restore facial expressions, and improve ease of movement, mood,&#xD;
      and sleep quality in patients with PD. Scientific evidence for the effectiveness of the&#xD;
      B.E.S.T. Hand Therapy appears to be lacking in the English language (Western) literature. The&#xD;
      goal of this pilot device feasibility study is to examine whether B.E.S.T. can increase&#xD;
      physical activity and functional fitness, enhance cognition, improve mood and subjective&#xD;
      sleep quality, and modulate resting tremor and gait parameters in PD patients over a 6-week&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Assessment of physical activity with body-worn sensor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visuospatial Cognition</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Assessment of visuospatial cognition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Mood will be assessed with questionnaires.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Sleep quality will be assessed with a questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting tremor</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Resting tremor will be assessed with body-worn sensors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Gait will be assessed with body-worn sensors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived pain</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Perceived pain will be assessed with a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and subjective health status</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>This questionnaire, called &quot;The 39-Item Parkinson's Disease Questionnaire&quot; (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 &quot;PDQ-39 Summary Index&quot; score will be calculated. Scores range from 0 (best quality of life) to 100 (worst quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity - Other</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Subjective physical activity will be assessed with a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Fitness</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Participants will undergo short field tests of functional fitness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition - Language</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Assessment of verbal fluency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition - Cognitive Control</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Assessment of executive functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition - learning and memory</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Assessment of learning and memory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>EH: Stimulation of Head Point</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS: Control Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-Tapper TT-R1</intervention_name>
    <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 &quot;Bio-Electro Stimulation Therapy&quot; known as the &quot;11-point Hand Treatment System&quot;. The current delivered is less than one milliampere.</description>
    <arm_group_label>CS: Control Stimulation</arm_group_label>
    <arm_group_label>EH: Stimulation of Head Point</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High functioning without presence of cognitive impairment or dementia&#xD;
&#xD;
          -  Native-English speaker or fluent in English&#xD;
&#xD;
          -  Diagnosis of Parkinson's disease (Hoehn &amp; Yahr stages I-III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Implanted medical devices, such as a pacemaker or defibrillator&#xD;
&#xD;
          -  Prescription medication or other drugs that affect the brain (e.g. anti-depressants,&#xD;
             anxiolytics), except prescription medication for the treatment of Parkinson's disease&#xD;
&#xD;
          -  Poor vision that cannot be corrected with glasses or contact lenses&#xD;
&#xD;
          -  Presence of musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint&#xD;
             pain)&#xD;
&#xD;
          -  Not being able to walk without assistance&#xD;
&#xD;
          -  Diagnosis of dementia or mild cognitive impairment&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Taking medications for diabetes mellitus&#xD;
&#xD;
          -  Skin irritation, disease or wound on the hands&#xD;
&#xD;
          -  Current heart conditions, such as congestive heart failure, tachycardia, or other&#xD;
             arrhythmias&#xD;
&#xD;
          -  History of heart attack&#xD;
&#xD;
          -  Psychiatric or neurological disorders other than Parkinson's disease (e.g. Major&#xD;
             Depressive Disorder, anxiety disorder, epilepsy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karin Schon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Karin Schon</investigator_full_name>
    <investigator_title>Assistant Professor, Anatomy &amp; Neurobiology</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>fitness</keyword>
  <keyword>cognition</keyword>
  <keyword>mood</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>sleep quality</keyword>
  <keyword>tremor</keyword>
  <keyword>gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014050
org study id: H-34609
secondary id: BEST-PD2017
nct id: NCT03014050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Physical activity
time frame: 10-12 weeks
description: Assessment of physical activity with body-worn sensor
measure: Visuospatial Cognition
time frame: 10-12 weeks
description: Assessment of visuospatial cognition
measure: Mood
time frame: 10-12 weeks
description: Mood will be assessed with questionnaires.
measure: Sleep quality
time frame: 10-12 weeks
description: Sleep quality will be assessed with a questionnaire.
measure: Resting tremor
time frame: 10-12 weeks
description: Resting tremor will be assessed with body-worn sensors.
measure: Gait
time frame: 10-12 weeks
description: Gait will be assessed with body-worn sensors.
measure: Perceived pain
time frame: 10-12 weeks
description: Perceived pain will be assessed with a questionnaire.
measure: Quality of life and subjective health status
time frame: 10-12 weeks
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).
measure: Physical activity - Other
time frame: 10-12 weeks
description: Subjective physical activity will be assessed with a questionnaire.
measure: Functional Fitness
time frame: 10-12 weeks
description: Participants will undergo short field tests of functional fitness.
measure: Cognition - Language
time frame: 10-12 weeks
description: Assessment of verbal fluency
measure: Cognition - Cognitive Control
time frame: 10-12 weeks
description: Assessment of executive functions
measure: Cognition - learning and memory
time frame: 10-12 weeks
description: Assessment of learning and memory
arm group label: EH: Stimulation of Head Point
arm group type: Experimental
description: Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1
arm group label: CS: Control Stimulation
arm group type: Active Comparator
description: Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1
intervention type: Device
intervention name: e-Tapper TT-R1
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.
arm group label: CS: Control Stimulation
arm group label: EH: Stimulation of Head Point
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Karin Schon, Ph.D.
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Karin Schon
investigator title: Assistant Professor, Anatomy & Neurobiology
mesh term: Parkinson Disease
sharing ipd: No