<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/NCT02207387</url>
  </required_header>
  <id_info>
    <org_study_id>H13-02074</org_study_id>
    <nct_id>NCT02207387</nct_id>
  </id_info>
  <brief_title>Ambulosono Rasagiline Musical Walking Study</brief_title>
  <official_title>A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <brief_summary>
    <textblock>
      This study will investigate the effects of a contingency-based musical walking intervention&#xD;
      program called Ambulosono on neural mechanisms in the brain. The investigators will&#xD;
      investigate the long-term impact of Ambulosono on brain plasticity with functional MRI&#xD;
      technique. Participants will undergo 3 months of Ambulosono training and their pre-training&#xD;
      and post-training fMRI brain scans will be compared to understand the neural networks and&#xD;
      brain mechanisms following this intervention. The investigators hypothesized that Ambulosono&#xD;
      may induce functional compensatory reorganization of neural networks in the brain. This&#xD;
      project will allow us to address the important potential confound of placebo influence and to&#xD;
      aid in optimizing this intervention program. Additionally, the investigators are hoping to&#xD;
      investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis&#xD;
      is that there will be a positive synergistic effect, and that exercise will augment the&#xD;
      effectiveness of rasagiline in treating Parkinson's symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in brain imaging signals (fMRI)</measure>
    <time_frame>one month and four months</time_frame>
    <description>resting state data task-evoked data cortical thickness volume sizes of specified brain structures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in motor symptoms of PD</measure>
    <time_frame>baseline and one month and four months</time_frame>
    <description>Motor Symptoms:&#xD;
UPDRS-III scores&#xD;
Time taken to perform TUG and One Leg Stand Balance Test&#xD;
Gait performance observed from Line Walking Test, 6-Minute Walking Test, Coordinated Arm and Leg Swing Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cognition of PD</measure>
    <time_frame>baseline and one month and four months</time_frame>
    <description>Cognition:&#xD;
MOCA scores&#xD;
Changes in reaction times (Simple Reaction Time Test, Trail Making Test A and B)&#xD;
Performance on Phonemic Verbal Fluency Test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in mood</measure>
    <time_frame>baseline and one month and four months</time_frame>
    <description>Beck's Inventory for Depression&#xD;
Beck's Inventory for Anxiety&#xD;
Parkinson Fatigue Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in impact/quality of life</measure>
    <time_frame>baseline and one month and four months</time_frame>
    <description>PDQ-39 Quality of Life Questionnaire</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>MCW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music Contingent Walking (MCW) group: study-specific musical device that measures gait and plays music in a portable manner as the participant is walking is set at a threshold individually calculated per participant, and the music will stop playing when walking strides fall below this threshold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCMW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NMW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-music walking (NMW/silent) group: no music on at all regardless of step size.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCW+rasagiline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music contingent walking with rasagiline group: same paradigm as the previous MCW, but with rasagiline prescribed as adjunct therapy.&#xD;
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MMW+rasagiline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-music (silent) walking with rasagiline group: same paradigm as the previous NMW, but with rasagiline prescribed as adjunct therapy.&#xD;
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azilect</intervention_name>
    <description>Rasagiline is Parkinson's medication that can be taken alone early in the disease or with other medication and is hypothesized to produce synergistic effects with exercise.</description>
    <arm_group_label>MCW+rasagiline</arm_group_label>
    <arm_group_label>MMW+rasagiline</arm_group_label>
    <other_name>rasagiline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.</description>
    <arm_group_label>MCW</arm_group_label>
    <arm_group_label>MCW+rasagiline</arm_group_label>
    <arm_group_label>MMW+rasagiline</arm_group_label>
    <arm_group_label>NCMW</arm_group_label>
    <arm_group_label>NMW</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <arm_group_label>MCW</arm_group_label>
    <arm_group_label>MCW+rasagiline</arm_group_label>
    <arm_group_label>NCMW</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 19 years of age&#xD;
&#xD;
          -  Confirmed diagnosis of Parkinson's Disease&#xD;
&#xD;
          -  Can walk 5 to 10 minutes unassisted&#xD;
&#xD;
          -  Have a safe place to walk (outdoor or indoor)&#xD;
&#xD;
          -  Have mild to moderate Parkinson's disease (HY1-3)&#xD;
&#xD;
          -  Be able to lay flat in the scanner for the period of the study&#xD;
&#xD;
          -  No reliance on wheelchair or other walking aid for ambulation&#xD;
&#xD;
          -  Absence of any other serious medical conditions such as hearing impairment and&#xD;
             dementia&#xD;
&#xD;
          -  No history of other neurological and psychiatric illnesses&#xD;
&#xD;
          -  No recent musculoskeletal impairment or injuries that may prevent walking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 19 years of age&#xD;
&#xD;
          -  Unconfirmed PD diagnosis&#xD;
&#xD;
          -  Require walking aid, wheelchair-bound&#xD;
&#xD;
          -  No access to safe walking pathway&#xD;
&#xD;
          -  Severe PD (Hoehn &amp; Yahr stages&gt;3)&#xD;
&#xD;
          -  Impaired hearing&#xD;
&#xD;
          -  Atypical Parkinsonism&#xD;
&#xD;
          -  Concurrent dementia&#xD;
&#xD;
          -  Recent knee, hip or foot injury (need permission from doctor)&#xD;
&#xD;
        Exclusion Criteria for fMRI&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Brain aneurysm clip&#xD;
&#xD;
          -  Cochlear implant&#xD;
&#xD;
          -  Recent surgery within the past 6 weeks&#xD;
&#xD;
          -  Possibility of pregnancy&#xD;
&#xD;
          -  Electrical stimulator for nerves or bones&#xD;
&#xD;
          -  Implanted infusion pump&#xD;
&#xD;
          -  History of any eye injury involving metal fragments&#xD;
&#xD;
          -  History of working with metals (grinding, machining, or welding)&#xD;
&#xD;
          -  Artificial heart valve&#xD;
&#xD;
          -  Orthopaedic hardware (artificial joint, plate, screws, rods)&#xD;
&#xD;
          -  Other metallic prostheses&#xD;
&#xD;
          -  Coil, catheter or filter in any blood vessel&#xD;
&#xD;
          -  Ear or eye implant&#xD;
&#xD;
          -  Recent tattoos within the past 6 weeks&#xD;
&#xD;
          -  Shrapnel, bullets, or other metallic fragments&#xD;
&#xD;
          -  Medication releasing skin patches (nicotine, birth control, nitroglycerine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin J McKeown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silke Cresswell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tammy Kang</last_name>
    <phone>604 822 9722</phone>
    <email>tammy.kang@ubc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pacific Parkinson's Research Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6P 2Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Martin J McKeown, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rasagiline</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02207387
org study id: H13-02074
nct id: NCT02207387
lead sponsor: 
collaborator: 
This study will investigate the effects of a contingency-based musical walking intervention
      program called Ambulosono on neural mechanisms in the brain. The investigators will
      investigate the long-term impact of Ambulosono on brain plasticity with functional MRI
      technique. Participants will undergo 3 months of Ambulosono training and their pre-training
      and post-training fMRI brain scans will be compared to understand the neural networks and
      brain mechanisms following this intervention. The investigators hypothesized that Ambulosono
      may induce functional compensatory reorganization of neural networks in the brain. This
      project will allow us to address the important potential confound of placebo influence and to
      aid in optimizing this intervention program. Additionally, the investigators are hoping to
      investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis
      is that there will be a positive synergistic effect, and that exercise will augment the
      effectiveness of rasagiline in treating Parkinson's symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in brain imaging signals (fMRI)
time frame: one month and four months
description: resting state data task-evoked data cortical thickness volume sizes of specified brain structures
measure: Change from baseline in motor symptoms of PD
time frame: baseline and one month and four months
description: Motor Symptoms:
UPDRS-III scores
Time taken to perform TUG and One Leg Stand Balance Test
Gait performance observed from Line Walking Test, 6-Minute Walking Test, Coordinated Arm and Leg Swing Test
measure: Change from baseline in cognition of PD
time frame: baseline and one month and four months
description: Cognition:
MOCA scores
Changes in reaction times (Simple Reaction Time Test, Trail Making Test A and B)
Performance on Phonemic Verbal Fluency Test
measure: Changes in mood
time frame: baseline and one month and four months
description: Beck's Inventory for Depression
Beck's Inventory for Anxiety
Parkinson Fatigue Scale
measure: Changes in impact/quality of life
time frame: baseline and one month and four months
description: PDQ-39 Quality of Life Questionnaire
arm group label: MCW
arm group type: Experimental
description: Music Contingent Walking (MCW) group: study-specific musical device that measures gait and plays music in a portable manner as the participant is walking is set at a threshold individually calculated per participant, and the music will stop playing when walking strides fall below this threshold.
arm group label: NCMW
arm group type: Experimental
description: Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
arm group label: NMW
arm group type: Experimental
description: Non-music walking (NMW/silent) group: no music on at all regardless of step size.
arm group label: MCW+rasagiline
arm group type: Experimental
description: Music contingent walking with rasagiline group: same paradigm as the previous MCW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
arm group label: MMW+rasagiline
arm group type: Experimental
description: Non-music (silent) walking with rasagiline group: same paradigm as the previous NMW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
intervention type: Drug
intervention name: Azilect
description: Rasagiline is Parkinson's medication that can be taken alone early in the disease or with other medication and is hypothesized to produce synergistic effects with exercise.
arm group label: MCW+rasagiline
arm group label: MMW+rasagiline
other name: rasagiline
intervention type: Behavioral
intervention name: Exercise
description: Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
arm group label: MCW
arm group label: MCW+rasagiline
arm group label: MMW+rasagiline
arm group label: NCMW
arm group label: NMW
intervention type: Other
intervention name: Music
arm group label: MCW
arm group label: MCW+rasagiline
arm group label: NCMW
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Martin J McKeown, MD
role: Principal Investigator
affiliation: University of British Columbia
last name: Silke Cresswell, MD
role: Principal Investigator
affiliation: University of British Columbia
last name: Tammy Kang
phone: 604 822 9722
email: tammy.kang@ubc.ca
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Rasagiline