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

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429909
• Other study ID #: CHU-0097
• Secondary ID: 2010-A01115-34
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: June 16, 2016
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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*.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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*.

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.		at day 1	Yes