Ambulosono Rasagiline Musical Walking Study

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02207387
• Other study ID #: H13-02074
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2014
• Last updated: March 31, 2015
• Start date: October 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: University of British Columbia
• Contact: Tammy Kang
• Phone: 604 822 9722
• Email: tammy.kang[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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.

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

Other:
• Music

Locations

Country	Name	City	State
Canada	Pacific Parkinson's Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Teva Pharmaceutical Industries

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in mood	Beck's Inventory for Depression; Beck's Inventory for Anxiety; Parkinson Fatigue Scale	baseline and one month and four months	No
Other	Changes in impact/quality of life	PDQ-39 Quality of Life Questionnaire	baseline and one month and four months	No
Primary	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	No
Secondary	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	No
Secondary	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	No