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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429909
First Posted: September 7, 2011
Last Update Posted: June 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
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*.

Condition Intervention
Parkinson's Disease Device: MAGNETOM Avanto (MRI device)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0. [ Time Frame: at day 1 ]

Enrollment: 19
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MAGNETOM Avanto (MRI device)
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429909


Locations
France
Chu Clermont-Ferrand
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Miguel ULLA University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01429909     History of Changes
Other Study ID Numbers: CHU-0097
2010-A01115-34 ( Registry Identifier: 2010-A01115-34 )
First Submitted: July 7, 2011
First Posted: September 7, 2011
Last Update Posted: June 17, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Functional magnetic resonance imaging
T2*
cortex and basal ganglia
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Ganglion Cysts
Synovial Cyst
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases


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