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Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease (2010-A01115-34)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MAGNETOM Avanto (MRI device)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Functional magnetic resonance imaging, T2*, cortex and basal ganglia, Parkinson's disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For patients :
  • Patients with idiopathic Parkinson's disease according to UKPDSBB criterias
  • Men or women aged between 40 to 80 years
  • not treated with deep brain stimulation

For healthy subjects

- Men or women aged between 40 to 80 years

Exclusion Criteria:

For patients

  • Dementia (MMS<24)
  • Contraindication to MRI.
  • Under guardianship
  • In excluding period for another study

For healthy subjects

  • Antecedent of neurodegenerative diseases or psychiatric diseases
  • Contraindication to MRI
  • Under guardianship
  • In excluding period for another study

Sites / Locations

  • Chu Clermont-Ferrand

Outcomes

Primary Outcome Measures

The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2011
Last Updated
June 16, 2016
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01429909
Brief Title
Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease
Acronym
2010-A01115-34
Official Title
Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease: T2* Measurement in the Cortex and the Basal Ganglia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing the fMRI for the study of the basal ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The T2 * is a tissue parameter dependent of iron content, which differs with brain structures and probably also with age and in case of neurodegenerative disease. Optimal TE s should correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
Detailed Description
80 subjects (40 PD patients and 40 paired healthy volunteers (on sex and age)) aged 40-80 years will be included. PD patients will be recruited in the Department of Neurology of CHU of Clermont-Ferrand. Healthy volunteers will be selected in clinical trial database. This study will consist of one visit (at J0) during which subjects will undergo a MRI (a single acquisition of 40 minutes approximately). PD patients will be further questioned on their disease and will benefit from a neurological examination

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Functional magnetic resonance imaging, T2*, cortex and basal ganglia, Parkinson's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
MAGNETOM Avanto (MRI device)
Intervention Description
The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
Primary Outcome Measure Information:
Title
The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For patients : Patients with idiopathic Parkinson's disease according to UKPDSBB criterias Men or women aged between 40 to 80 years not treated with deep brain stimulation For healthy subjects - Men or women aged between 40 to 80 years Exclusion Criteria: For patients Dementia (MMS<24) Contraindication to MRI. Under guardianship In excluding period for another study For healthy subjects Antecedent of neurodegenerative diseases or psychiatric diseases Contraindication to MRI Under guardianship In excluding period for another study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel ULLA
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
Country
France

12. IPD Sharing Statement

Learn more about this trial

Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease

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