Parkinson DiseaseNCT02265900
Parkinson's Disease Exercise TMS PET Study
A study testing Exercise in people with Parkinson Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
Trial summary
The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported, however the mechanisms are unknown. The purpose of this study is to investigate the potential mechanisms of exercise in the brain for the treatment of PD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to 12 Mar 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Diagnosed with Parkinson's Disease, Exercise less than 3x per week.
Exclusion Criteria. Describe which potential participants will be excluded from participation, and list the criteria for their exclusion.
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
- other neurological disease/complications (e.g. myopathy, stroke, brain lesion, MS);
- self-reports claustrophobia;
- history of cancer within 5 years of study participation;
- high dose of radiation from other procedures within the year;
- not able to tolerate being off PD medication for up to 24 hours;
- a female subject who is breast-feeding or pregnant.
- Subjects who regularly use anti-inflammatories (only excluded for PBR scans).
Exclusion criteria for MRI scanning and magnetic stimulation from repetitive Transcranial Magnetic Stimulation (rTMS) scanning includes:
- artificial heart valve;
- brain aneurysm clip;
- electrical stimulator for nerves or bones;
- ear or eye implant;
- implanted drug infusion pump;
- coil, catheter, or filter in any blood vessel;
- orthopedic hardware (artificial joint, plate, screws);
- other metallic prostheses;
- shrapnel, bullets, or other metal fragments;
- surgery or tattoos (including tattooed eyeliner) in the last six weeks;
- brain surgery
- have a cardiac pacemaker, wires or defibrillator;
- have had an injury where a piece of metal lodged in the eye or orbit;
- have a ferromagnetic aneurysm clip; and
- have a history of seizures/epilepsy
- history of severe or uncontrolled headaches/migraines
- taking medications that lower seizure threshold (e.g. amitryptiline, haloperidol)
Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
- significant cognitive impairment or depression;
- significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
- failure to comply with the exercise or stretching intervention program by not completing at least 30 of the 36 exercise classes.
- Severe/multiple head trauma(s)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Exercise and Parkinson's Disease: The Basis for Motor and Cognitive Benefits
The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported, however the mechanisms are unknown. The purpose of this study is to investigate the potential mechanisms of exercise in the brain for the treatment of PD.
Read the detailed description
Positron Emission Tomography will be used to measure dopamine neuron density, endogenous dopamine release and neuroimflammation. We will also use functional magnetic resonance imaging (fMRI) to measure brain activity. Assessments will be conducted before and after a 12-week exercise intervention and 3-year follow-up. Participants will be randomly allocated into either an aerobic or a stretching intervention. Clinical measures of motor function, cognition and mood will also be assessed.
- Conditions
- Parkinson Disease
- Being tested
- Exercise
- Keywords
- Positron Emission Tomography, Dopamine, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
One type of exercise
ExerciseOther
A different type of exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise 1 | Active comparator | One type of exercise Receives: Other: Exercise |
| Exercise 2 | Placebo comparator | A different type of exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dopamine release measured by RAC PET
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Covid Restrictions have impacted longitudinal assessments for the effect of the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Parkinson's Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Jon Stoessl, Pacific Parkinson's Research Centre
- Investigators
- A.J. Stoessl, MD, Principal investigator, Pacific Parkinson's Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265900
- Sponsor's protocol ID
- H14-02200
- Status last verified
- Mar 2021
- First submitted
- 11 Oct 2014
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Parkinson's Disease: The Basis for Motor and Cognitive Benefits
- ClinicalTrials.gov ID
- NCT02265900
- Acronym / sponsor ID
- H14-02200
- Conditions
- Parkinson Disease
- Keywords
- Positron Emission Tomography, Dopamine, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid Restrictions have impacted longitudinal assessments for the effect of the intervention
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pacific Parkinson's Research CentreUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 16 Oct 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.
The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported, however the mechanisms are unknown. The purpose of this study is to investigate the potential mechanisms of exercise in the brain for the treatment of PD.
Detailed description
Positron Emission Tomography will be used to measure dopamine neuron density, endogenous dopamine release and neuroimflammation. We will also use functional magnetic resonance imaging (fMRI) to measure brain activity. Assessments will be conducted before and after a 12-week exercise intervention and 3-year follow-up. Participants will be randomly allocated into either an aerobic or a stretching intervention. Clinical measures of motor function, cognition and mood will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise 1 | Active comparator | Other: ExerciseOne type of exercise |
| Exercise 2 | Placebo comparator | Other: ExerciseA different type of exercise |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ExerciseOne type of exercise | Other | Exercise 1 |
| ExerciseA different type of exercise | Other | Exercise 2 |
Primary outcome
Change in Dopamine release measured by RAC PET
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Covid Restrictions have impacted longitudinal assessments for the effect of the intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
A.J. Stoessl, MD principal investigator
Pacific Parkinson's Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease, run by Pacific Parkinson's Research Centre 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?
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: stopped early, as of the sponsor's last update on 17 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Covid Restrictions have impacted longitudinal assessments for the effect of the intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dopamine release measured by RAC PET (time frame: 4 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 17 Mar 2021.