Ambulosono Rasagiline Musical Walking Study
A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
August 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 2, 2015
March 1, 2015
3.4 years
July 28, 2014
March 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change from baseline in motor symptoms of PD
baseline and one month and four months
Change from baseline in cognition of PD
baseline and one month and four months
Other Outcomes (2)
Changes in mood
baseline and one month and four months
Changes in impact/quality of life
baseline and one month and four months
Study Arms (5)
MCW
EXPERIMENTALMusic 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.
NCMW
EXPERIMENTALNon-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
NMW
EXPERIMENTALNon-music walking (NMW/silent) group: no music on at all regardless of step size.
MCW+rasagiline
EXPERIMENTALMusic 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
MMW+rasagiline
EXPERIMENTALNon-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
Interventions
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.
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Pacemaker
- Brain aneurysm clip
- Cochlear implant
- Recent surgery within the past 6 weeks
- Possibility of pregnancy
- Electrical stimulator for nerves or bones
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6P 2Z9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin J McKeown, MD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Silke Cresswell, MD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2014
First Posted
August 4, 2014
Study Start
October 1, 2013
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
April 2, 2015
Record last verified: 2015-03