Recruiting

Ambulosono & Rasagiline

Sponsor:

University of British Columbia

Code:

NCT02207387

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Azilect

Exercise

Music

Study Details

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.

Conditions

Parkinson's Disease

Study ID

NCT02207387

Start date

Oct, 2013

Status verified date

Mar, 2015

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: NCMW

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

experimental: NMW

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

experimental: 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

experimental: 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

Interventions

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.

Exercise

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

Music

Primary outcome measure

  • Change from baseline in brain imaging signals (fMRI) [ Time Frame: one month and four months ]

Central Contacts and Locations

Central contacts

Tammy Kang

604 822 9722tammy.kang@ubc.ca

Locations

Pacific Parkinson's Research Centre

Recruiting

Vancouver, British Columbia, Canada, V6P 2Z9

Principal Investigator:

Martin J McKeown, MD

More Information

Sponsor

University of British Columbia

Last update posted

Apr 2, 2015

Last verified

Mar, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-04-02.