7T MRS in Parkinson's Disease | NCT01237210

Studies
7T MRS in Parkinson's Disease

NCT01237210

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Nov 1, 2019Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Nov 8, 2010

First Submission Date that Met QC Criteria

Nov 8, 2010

First Posted Date

Nov 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2019

Last Update Posted Date

Nov 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.
There will be a relationship between neurochemical changes and disease severity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Parkinson's patients and healthy controls

Sampling Method

Non-Probability Sample

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases