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Completed

NCT Number: NCT02455284

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

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.

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Key information

Conditions

Neurological Diseases

Age range

82 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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

Primary outcomes

  1. Reconstructions of the fiber tracts

    Time frame: 5.5 years

    similarity indices, such as modified Haussdorf distance, measured on MRI images

Secondary outcomes

  1. Number of subjects included in the database

    Time frame: 5.5 years

    Number of subjects included in the database

  2. Scores at neuropsychological evaluation

    Time frame: 5.5 years

    Scores at neuropsychological evaluation

  3. In vivo MRI measures obtained from DWI

    Time frame: 5.5 years

    In vivo MRI measures obtained from DWI

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: FIBRATLAS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 27, 2015
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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