Ambulosono Rasagiline Musical Walking Study

March 31, 2015 updated by: University of British Columbia

A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6P 2Z9
        • Recruiting
        • Pacific Parkinson's Research Centre
        • Principal Investigator:
          • Martin J McKeown, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 19 years of age
  • Confirmed diagnosis of Parkinson's Disease
  • Can walk 5 to 10 minutes unassisted
  • Have a safe place to walk (outdoor or indoor)
  • Have mild to moderate Parkinson's disease (HY1-3)
  • Be able to lay flat in the scanner for the period of the study
  • No reliance on wheelchair or other walking aid for ambulation
  • Absence of any other serious medical conditions such as hearing impairment and dementia
  • No history of other neurological and psychiatric illnesses
  • No recent musculoskeletal impairment or injuries that may prevent walking

Exclusion Criteria:

  • Under 19 years of age
  • Unconfirmed PD diagnosis
  • Require walking aid, wheelchair-bound
  • No access to safe walking pathway
  • Severe PD (Hoehn & Yahr stages>3)
  • Impaired hearing
  • Atypical Parkinsonism
  • Concurrent dementia
  • Recent knee, hip or foot injury (need permission from doctor)

Exclusion Criteria for fMRI

  • Pacemaker
  • Brain aneurysm clip
  • Cochlear implant
  • Recent surgery within the past 6 weeks
  • Possibility of pregnancy
  • Electrical stimulator for nerves or bones
  • Implanted infusion pump
  • History of any eye injury involving metal fragments
  • History of working with metals (grinding, machining, or welding)
  • Artificial heart valve
  • Orthopaedic hardware (artificial joint, plate, screws, rods)
  • Other metallic prostheses
  • Coil, catheter or filter in any blood vessel
  • Ear or eye implant
  • Recent tattoos within the past 6 weeks
  • Shrapnel, bullets, or other metallic fragments
  • Medication releasing skin patches (nicotine, birth control, nitroglycerine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCW
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.
Other: Music
Behavioral: Exercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Experimental: NCMW
Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
Other: Music
Behavioral: Exercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Experimental: NMW
Non-music walking (NMW/silent) group: no music on at all regardless of step size.
Behavioral: Exercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Experimental: MCW+rasagiline

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
Other: Music
Behavioral: Exercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Drug: Azilect
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.
Other Names:
  • rasagiline
Experimental: MMW+rasagiline

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
Behavioral: Exercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Drug: Azilect
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.
Other Names:
  • rasagiline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in brain imaging signals (fMRI)
Time Frame: one month and four months
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
one month and four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in motor symptoms of PD
Time Frame: baseline and one month and four months

Motor Symptoms:

  1. UPDRS-III scores
  2. Time taken to perform TUG and One Leg Stand Balance Test
  3. Gait performance observed from Line Walking Test, 6-Minute Walking Test, Coordinated Arm and Leg Swing Test
baseline and one month and four months
Change from baseline in cognition of PD
Time Frame: baseline and one month and four months

Cognition:

  1. MOCA scores
  2. Changes in reaction times (Simple Reaction Time Test, Trail Making Test A and B)
  3. Performance on Phonemic Verbal Fluency Test
baseline and one month and four months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mood
Time Frame: baseline and one month and four months
  1. Beck's Inventory for Depression
  2. Beck's Inventory for Anxiety
  3. Parkinson Fatigue Scale
baseline and one month and four months
Changes in impact/quality of life
Time Frame: baseline and one month and four months
PDQ-39 Quality of Life Questionnaire
baseline and one month and four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: Martin J McKeown, MD, University of British Columbia
  • Principal Investigator: Silke Cresswell, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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