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Ambulosono Rasagiline Musical Walking Study

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Azilect
Exercise
Music
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pacific Parkinson's Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

MCW

NCMW

NMW

MCW+rasagiline

MMW+rasagiline

Arm 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.

Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.

Non-music walking (NMW/silent) group: no music on at all regardless of step size.

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

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

Outcomes

Primary Outcome Measures

Change from baseline in brain imaging signals (fMRI)
resting state data task-evoked data cortical thickness volume sizes of specified brain structures

Secondary Outcome Measures

Change from baseline in motor symptoms of PD
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
Change from baseline in cognition of PD
Cognition: MOCA scores Changes in reaction times (Simple Reaction Time Test, Trail Making Test A and B) Performance on Phonemic Verbal Fluency Test

Full Information

First Posted
July 28, 2014
Last Updated
March 31, 2015
Sponsor
University of British Columbia
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02207387
Brief Title
Ambulosono Rasagiline Musical Walking Study
Official Title
A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCW
Arm Type
Experimental
Arm 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 Title
NCMW
Arm Type
Experimental
Arm Description
Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
Arm Title
NMW
Arm Type
Experimental
Arm Description
Non-music walking (NMW/silent) group: no music on at all regardless of step size.
Arm Title
MCW+rasagiline
Arm Type
Experimental
Arm 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 Title
MMW+rasagiline
Arm Type
Experimental
Arm 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(s)
Azilect
Other Intervention Name(s)
rasagiline
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Intervention Type
Other
Intervention Name(s)
Music
Primary Outcome Measure Information:
Title
Change from baseline in brain imaging signals (fMRI)
Description
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
Time Frame
one month and four months
Secondary Outcome Measure Information:
Title
Change from baseline in motor symptoms of PD
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
Time Frame
baseline and one month and four months
Title
Change from baseline in cognition of PD
Description
Cognition: MOCA scores Changes in reaction times (Simple Reaction Time Test, Trail Making Test A and B) Performance on Phonemic Verbal Fluency Test
Time Frame
baseline and one month and four months
Other Pre-specified Outcome Measures:
Title
Changes in mood
Description
Beck's Inventory for Depression Beck's Inventory for Anxiety Parkinson Fatigue Scale
Time Frame
baseline and one month and four months
Title
Changes in impact/quality of life
Description
PDQ-39 Quality of Life Questionnaire
Time Frame
baseline and one month and four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Kang
Phone
604 822 9722
Email
tammy.kang@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J McKeown, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silke Cresswell, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Parkinson's Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6P 2Z9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin J McKeown, MD

12. IPD Sharing Statement

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Ambulosono Rasagiline Musical Walking Study

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