Clinical trial NCT02455284: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
Official title: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Diseases
Keywords: MRI
Tractography
white
physiology
analysis
matter
tracts
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 134
Sex: ALL
Minimum age (years): 82
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.


Eligibility criteria: Inclusion Criteria:

* Prior enrollment in a body donation program
* Age ≥ 82 years
* Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969)
* Distance to one of the participating laboratories ≤ 120km
* Able to remain supine in the MR scanner for acquisition duration (60 min),
* Affiliation to Social Security
* Informed and written consent

Non Inclusion Criteria:

* Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions)
* Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia
* Contraindications to MRI
* Contraindication to body donation

Exclusion criteria

* Diagnosis on MRI of brain lesions, excepted common age-related changes

Primary outcomes:
measure: Reconstructions of the fiber tracts
timeFrame: 5.5 years
Secondary outcomes:
measure: Number of subjects included in the database
timeFrame: 5.5 years
measure: Scores at neuropsychological evaluation
timeFrame: 5.5 years
measure: In vivo MRI measures obtained from DWI
timeFrame: 5.5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital of Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Brest
country: France
facility: University Hospital of Brest
city: Lyon
country: France
facility: Hospital of Charpennes - Lyon
city: Nancy
country: France
facility: University Hospital of Nancy
city: Rennes
country: France
facility: University Hospital of Rennes
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Christophe DESTRIEUX, PhD
role: PRINCIPAL_INVESTIGATOR
References: