An interventional study of Azilect and Exercise in Parkinson's Disease, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-04-02.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for fMRI
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 · Other: Music
Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
Behavioral: Exercise · Other: Music
Non-music walking (NMW/silent) group: no music on at all regardless of step size.
Behavioral: Exercise
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 · Behavioral: Exercise · Other: Music
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 · Behavioral: Exercise
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.
Also known as: rasagiline
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
Change from baseline in brain imaging signals (fMRI)
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
Time frame: one month and four months
Change from baseline in motor symptoms of PD
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
Time frame: baseline and one month and four months
Change from baseline in cognition of PD
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
Time frame: baseline and one month and four months
Changes in mood
1. Beck's Inventory for Depression 2. Beck's Inventory for Anxiety 3. Parkinson Fatigue Scale
Time frame: baseline and one month and four months
Changes in impact/quality of life
PDQ-39 Quality of Life Questionnaire
Time frame: baseline and one month and four months
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rasagiline
University of British Columbia →