7T MRS in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01237210
First received: November 8, 2010
Last updated: December 8, 2015
Last verified: December 2015
  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 ] [ Designated as safety issue: No ]
    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 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 8, 2010
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 25, 2016