Ambulosono Rasagiline Musical Walking Study

NCT ID: NCT02207387

Last Updated: 2015-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-03-31

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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MCW

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

Music

Intervention Type OTHER

NCMW

Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

Music

Intervention Type OTHER

NMW

Non-music walking (NMW/silent) group: no music on at all regardless of step size.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

MCW+rasagiline

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

Group Type EXPERIMENTAL

Azilect

Intervention Type DRUG

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.

Exercise

Intervention Type BEHAVIORAL

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

Music

Intervention Type OTHER

MMW+rasagiline

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

Group Type EXPERIMENTAL

Azilect

Intervention Type DRUG

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.

Exercise

Intervention Type BEHAVIORAL

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

Interventions

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Azilect

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.

Intervention Type DRUG

Exercise

Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.

Intervention Type BEHAVIORAL

Music

Intervention Type OTHER

Other Intervention Names

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rasagiline

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)


* 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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin J McKeown, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Silke Cresswell, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Pacific Parkinson's Research Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Tammy Kang

Role: CONTACT

604 822 9722

Other Identifiers

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H13-02074

Identifier Type: -

Identifier Source: org_study_id

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