Status:

UNKNOWN

Ambulosono Rasagiline Musical Walking Study

Lead Sponsor:

University of British Columbia

Collaborating Sponsors:

Teva Branded Pharmaceutical Products R&D, Inc.

Conditions:

Parkinson's Disease

Eligibility:

All Genders

19+ years

Phase:

NA

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-ter...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

October 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2017

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02207387

Start Date

October 1 2013

End Date

March 1 2017

Last Update

April 2 2015

Active Locations (1)

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Pacific Parkinson's Research Centre

Vancouver, British Columbia, Canada, V6P 2Z9