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Parkinson's Disease Exercise TMS PET Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02265900
Recruitment Status : Terminated (Covid Restrictions have impacted longitudinal assessments for the effect of the intervention)
First Posted : October 16, 2014
Last Update Posted : March 17, 2021
Information provided by (Responsible Party):
A. Jon Stoessl, Pacific Parkinson's Research Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise and Parkinson's Disease: The Basis for Motor and Cognitive Benefits
Study Start Date : November 2014
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exercise 1
One type of exercise
Other: Exercise
One type of exercise

Placebo Comparator: Exercise 2
A different type of exercise
Other: Exercise
A different type of exercise

Primary Outcome Measures :
  1. Change in Dopamine release measured by RAC PET [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  1. atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
  2. significant osteoporosis or arthritis;
  3. other neurological disease/complications (e.g. myopathy, stroke, brain lesion, MS);
  4. self-reports claustrophobia;
  5. history of cancer within 5 years of study participation;
  6. high dose of radiation from other procedures within the year;
  7. not able to tolerate being off PD medication for up to 24 hours;
  8. a female subject who is breast-feeding or pregnant.
  9. 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:

  1. artificial heart valve;
  2. brain aneurysm clip;
  3. electrical stimulator for nerves or bones;
  4. ear or eye implant;
  5. implanted drug infusion pump;
  6. coil, catheter, or filter in any blood vessel;
  7. orthopedic hardware (artificial joint, plate, screws);
  8. other metallic prostheses;
  9. shrapnel, bullets, or other metal fragments;
  10. surgery or tattoos (including tattooed eyeliner) in the last six weeks;
  11. brain surgery
  12. have a cardiac pacemaker, wires or defibrillator;
  13. have had an injury where a piece of metal lodged in the eye or orbit;
  14. have a ferromagnetic aneurysm clip; and
  15. have a history of seizures/epilepsy
  16. history of severe or uncontrolled headaches/migraines
  17. 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:

  1. significant cognitive impairment or depression;
  2. significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
  3. failure to comply with the exercise or stretching intervention program by not completing at least 30 of the 36 exercise classes.
  4. Severe/multiple head trauma(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02265900

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Canada, British Columbia
Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
Pacific Parkinson's Research Centre
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Principal Investigator: A.J. Stoessl, MD Pacific Parkinson's Research Centre
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Responsible Party: A. Jon Stoessl, Director of Clinical PET, Pacific Parkinson's Research Centre Identifier: NCT02265900    
Other Study ID Numbers: H14-02200
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by A. Jon Stoessl, Pacific Parkinson's Research Centre:
Positron Emission Tomography
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases