Ambulosono Rasagiline Musical Walking Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Azilect
* Behavioral: Exercise
* Other: Music


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in brain imaging signals (fMRI) | 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 | 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 | baseline and one month and four months | 
| 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 | baseline and one month and four months |