Ambulosono Rasagiline Musical Walking Study

University of British Columbia

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Behavioral: Exercise; Other: Music; Drug: Azilect

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02207387

H13-02074

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 5 patient groups

MCW

Experimental group

Description:

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.

Treatment:

Other: Music

Behavioral: Exercise

NCMW

Experimental group

Description:

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

Treatment:

Other: Music

Behavioral: Exercise

NMW

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

MCW+rasagiline

Experimental group

Description:

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

Treatment:

Other: Music

Drug: Azilect

Behavioral: Exercise

MMW+rasagiline

Experimental group

Description:

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

Treatment:

Drug: Azilect

Behavioral: Exercise