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7T MRS in Parkinson's Disease

This study is currently recruiting participants.
Verified August 2016 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237210
First Posted: November 9, 2010
Last Update Posted: August 29, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose

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
Parkinson's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 26
Study Start Date: February 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
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
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
United States, Minnesota
University of Minnesota/CMRR Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Susan Rolandelli, RN    612-624-7745    cnru@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Paul Tuite, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01237210     History of Changes
Other Study ID Numbers: 7T
First Submitted: November 8, 2010
First Posted: November 9, 2010
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Parkinson's Disease
PD
magnetic resonance spectroscopy

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