Clinical trial NCT02207387: Ambulosono Rasagiline Musical Walking Study
Official title: A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2014-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change from baseline in brain imaging signals (fMRI)
timeFrame: one month and four months
Secondary outcomes:
measure: Change from baseline in motor symptoms of PD
timeFrame: baseline and one month and four months
measure: Change from baseline in cognition of PD
timeFrame: baseline and one month and four months
Other outcomes:
measure: Changes in mood
timeFrame: baseline and one month and four months
measure: Changes in impact/quality of life
timeFrame: baseline and one month and four months
Locations:
city: Vancouver
country: Canada
facility: Pacific Parkinson's Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Martin J McKeown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Silke Cresswell, MD
role: PRINCIPAL_INVESTIGATOR
References: