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7T MRS in Parkinson's Disease

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.
 
ClinicalTrials.gov Identifier: NCT01237210
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:

This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan.

  1. The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.
  2. There will be a relationship between neurochemical changes and disease severity.

Condition or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla
Actual Study Start Date : February 2010
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Magnetic resonance spectroscopy (MRS) [ Time Frame: Baseline ]
    We will utilize optimized magnetic resonance spectroscopy (MRS) methodology to address theories of pathogenesis of Parkinson's disease (PD) by quantifying glutathione (GSH), lactate, glutamine and myo-inositol levels of the unilateral substantia nigra (SN) of healthy volunteers and patients with PD.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's patients and healthy controls
Criteria

Inclusion Criteria:

Parkinson's disease Group

  • Parkinson's disease (clinical diagnostic criteria)
  • Age 45-75 years inclusive
  • Able to safely undergo MRI scanning
  • Absence of diabetes and smoking
  • Capable of giving informed consent

Healthy Control Group

  • Age 45-75 years inclusive
  • Able to safely undergo MRI scanning
  • Absence of diabetes and smoking
  • Capable of giving informed consent

Exclusion Criteria:

Parkinson's disease Group

  • Dementia (clinically determined by PI Dr. Tuite)
  • Diagnosis of atypical parkinsonism
  • Inability to safely undergo MRI scanning
  • Inability to give informed consent
  • Unstable medical conditions
  • Present smoker
  • Diabetic (on oral or injectable medications for diabetes)
  • Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
  • Does not meet age criteria

Healthy Control Group

  • Has a 1st degree relative with PD
  • Dementia (clinically determined by PI Dr. Tuite)
  • Inability to safely undergo MRI scanning
  • Inability to give informed consent
  • Unstable medical conditions
  • Present smoker
  • Diabetic (on oral or injectable medications for diabetes)
  • Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
  • Does not meet age criteria
Contacts and Locations
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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): NCT01237210


Locations
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United States, Minnesota
University of Minnesota/CMRR
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Paul Tuite, MD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01237210    
Other Study ID Numbers: 0803M28421
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by University of Minnesota:
Parkinson's Disease
PD
magnetic resonance spectroscopy
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
Synucleinopathies
Neurodegenerative Diseases