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Parkinson's Disease Exercise TMS PET Study

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ClinicalTrials.gov Identifier: NCT02265900
Recruitment Status : Recruiting
First Posted : October 16, 2014
Last Update Posted : November 7, 2017
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02265900


Contacts
Contact: Nicole Heffernan 604-822-7705

Locations
Canada, British Columbia
Pacific Parkinson's Research Centre Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Matthew Sacheli, MSc    604-827-1353      
Principal Investigator: A. Jon Stoessl, MD         
Sponsors and Collaborators
Pacific Parkinson's Research Centre
Investigators
Principal Investigator: A.J. Stoessl, MD Pacific Parkinson's Research Centre

Responsible Party: A. Jon Stoessl, Director of Clinical PET, Pacific Parkinson's Research Centre
ClinicalTrials.gov Identifier: NCT02265900     History of Changes
Other Study ID Numbers: H14-02200
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by A. Jon Stoessl, Pacific Parkinson's Research Centre:
Positron Emission Tomography
Dopamine
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases