Parkinson's Disease
Conditions
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.
Interventions
DRUGAzilect
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.
BEHAVIORALExercise
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
OTHERMusic
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in brain imaging signals (fMRI) | one month and four months | resting state data task-evoked data cortical thickness volume sizes of specified brain structures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in motor symptoms of PD | 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 |
| Change from baseline in cognition of PD | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in mood | baseline and one month and four months | 1. Beck's Inventory for Depression 2. Beck's Inventory for Anxiety 3. Parkinson Fatigue Scale |
| Changes in impact/quality of life | baseline and one month and four months | PDQ-39 Quality of Life Questionnaire |
Countries
Canada
Contacts
Primary ContactTammy Kang
Outcome results
None listed