In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

Neurological Diseases Clinical Trial

— FIBRATLAS  

Official title:

In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455284
• Other study ID #: ANR 14 - CD / FIBRATLAS
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 82 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases

Intervention

Device:
• MRI
In vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images

Locations

Country	Name	City	State
France	University Hospital of Amiens	Amiens
France	University Hospital of Angers	Angers
France	University Hospital of Brest	Brest
France	Hospital of Charpennes - Lyon	Lyon
France	University Hospital of Nancy	Nancy
France	University Hospital of Rennes	Rennes
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconstructions of the fiber tracts	similarity indices, such as modified Haussdorf distance, measured on MRI images	5.5 years
Secondary	Number of subjects included in the database	Number of subjects included in the database	5.5 years
Secondary	Scores at neuropsychological evaluation	Scores at neuropsychological evaluation	5.5 years
Secondary	In vivo MRI measures obtained from DWI	In vivo MRI measures obtained from DWI	5.5 years