Parkinson's DiseaseNCT02207387
Ambulosono Rasagiline Musical Walking Study
A study testing Azilect, Exercise and Music in people with Parkinson's Disease, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Azilect, Exercise and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6P 2Z9
Martin J McKeown, MD
About this study
Official title: A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
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
- Being tested
- Azilect, Exercise, Music
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzilectDrug
Also called rasagiline
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.
ExerciseBehavioural
Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
MusicOther
| Study group | Role | What they receive |
|---|---|---|
| MCW | Experimental | 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. Receives: Behavioral: Exercise; Other: Music |
| NCMW | Experimental | Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size. Receives: Behavioral: Exercise; Other: Music |
| NMW | Experimental | Non-music walking (NMW/silent) group: no music on at all regardless of step size. Receives: Behavioral: Exercise |
| MCW+rasagiline | Experimental | 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 Receives: Drug: Azilect; Behavioral: Exercise; Other: Music |
| MMW+rasagiline | Experimental | 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 Receives: Drug: Azilect; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in brain imaging signals (fMRI)
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
Measured: one month and four months
Secondary outcomes (2)
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
Measured: baseline and one month and four months
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
Measured: baseline and one month and four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Martin J McKeown, MD, Principal investigator, University of British ColumbiaSilke Cresswell, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207387
- Sponsor's protocol ID
- H13-02074
- Status last verified
- Mar 2015
- First submitted
- 28 Jul 2014
- Last updated
- 2 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02207387
- Acronym / sponsor ID
- H13-02074
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MCW | Experimental | Behavioral: Exercise, Other: MusicMusic 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. |
| NCMW | Experimental | Behavioral: Exercise, Other: MusicNon-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size. |
| NMW | Experimental | Behavioral: ExerciseNon-music walking (NMW/silent) group: no music on at all regardless of step size. |
| MCW+rasagiline | Experimental | Drug: Azilect, Behavioral: Exercise, Other: MusicMusic 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 |
| MMW+rasagiline | Experimental | Drug: Azilect, Behavioral: ExerciseNon-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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzilectAlso: rasagilineRasagiline 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. | Drug | MCW+rasagiline, MMW+rasagiline |
| ExerciseWalking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms. | Behavioural | MCW, MCW+rasagiline, MMW+rasagiline, NCMW, NMW |
| Music | Other | MCW, MCW+rasagiline, NCMW |
Primary outcome
Change from baseline in brain imaging signals (fMRI)
Time frame: one month and four months
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
2 secondary outcomes
Change from baseline in motor symptoms of PD
Time frame: baseline and one month and four months
Change from baseline in cognition of PD
Time frame: baseline and one month and four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin J McKeown, MD principal investigator
University of British Columbia
Silke Cresswell, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azilect, Exercise and Music in people with Parkinson's Disease, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tammy Kang (604 822 9722, tammy.kang@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in brain imaging signals (fMRI) (time frame: one month and four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.