NCT01429909

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\*.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

July 7, 2011

Last Update Submit

June 16, 2016

Conditions

Keywords

Functional magnetic resonance imagingT2*cortex and basal gangliaParkinson's disease

Outcome Measures

Primary Outcomes (1)

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

    at day 1

Interventions

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\*.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Miguel ULLA

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

September 7, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 17, 2016

Record last verified: 2016-06

Locations