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

NCT ID: NCT01429909

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-12-31

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

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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\*.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel ULLA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2010-A01115-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-0097

Identifier Type: -

Identifier Source: org_study_id