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Parkinson's Disease Exercise TMS PET Study

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Exercise
Sponsored by
Pacific Parkinson's Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Positron Emission Tomography, Dopamine, Parkinson's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pacific Parkinson's Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercise 1

Exercise 2

Arm Description

One type of exercise

A different type of exercise

Outcomes

Primary Outcome Measures

Change in Dopamine release measured by RAC PET

Secondary Outcome Measures

Full Information

First Posted
October 11, 2014
Last Updated
March 15, 2021
Sponsor
Pacific Parkinson's Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02265900
Brief Title
Parkinson's Disease Exercise TMS PET Study
Official Title
Exercise and Parkinson's Disease: The Basis for Motor and Cognitive Benefits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid Restrictions have impacted longitudinal assessments for the effect of the intervention
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Parkinson's Research Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Positron Emission Tomography, Dopamine, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise 1
Arm Type
Active Comparator
Arm Description
One type of exercise
Arm Title
Exercise 2
Arm Type
Placebo Comparator
Arm Description
A different type of exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
One type of exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
A different type of exercise
Primary Outcome Measure Information:
Title
Change in Dopamine release measured by RAC PET
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.J. Stoessl, MD
Organizational Affiliation
Pacific Parkinson's Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Parkinson's Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada

12. IPD Sharing Statement

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Parkinson's Disease Exercise TMS PET Study

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