Parkinson's Disease Exercise TMS PET Study

March 15, 2021 updated by: A. Jon Stoessl, Pacific Parkinson's Research Centre

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Pacific Parkinson's Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Exercise 1
One type of exercise
Other: Exercise
One type of exercise
Other: Exercise
A different type of exercise
PLACEBO_COMPARATOR: Exercise 2
A different type of exercise
Other: Exercise
One type of exercise
Other: Exercise
A different type of exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Dopamine release measured by RAC PET
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Parkinson's Research Centre

Investigators

  • Principal Investigator: A.J. Stoessl, MD, Pacific Parkinson's Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

March 12, 2020

Study Completion (ACTUAL)

March 12, 2020

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

October 11, 2014

First Posted (ESTIMATE)

October 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-02200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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