7T MRS in Parkinson's Disease

October 30, 2019 updated by: University of Minnesota

Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota/CMRR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's patients and healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Paul Tuite, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0803M28421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe