7T MRS in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237210
• Other study ID #: 0803M28421
• Status: Completed
• Start date: February 2010
• Est. completion date: February 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	University of Minnesota/CMRR	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic resonance spectroscopy (MRS)	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