Parkinson's Disease Exercise TMS PET Study

NCT ID: NCT02265900

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2020-03-12

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Exercise 1

One type of exercise

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

One type of exercise

Exercise 2

A different type of exercise

Group Type: PLACEBO_COMPARATOR

Exercise

Intervention Type: OTHER

A different type of exercise

Interventions

Exercise

One type of exercise

Intervention Type: OTHER

Exercise

A different type of exercise

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

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).

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)

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacific Parkinson's Research Centre

OTHER

Sponsor Role: lead

Responsible Party

A. Jon Stoessl

Director of Clinical PET

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A.J. Stoessl, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Parkinson's Research Centre

Locations

Pacific Parkinson's Research Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H14-02200

Identifier Type: -

Identifier Source: org_study_id