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Clinical Trials/NCT02455284
NCT02455284CompletedNot Applicable

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

University Hospital, Tours14 sites in 1 country134 target enrollmentStarted: October 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
134
Locations
14
Primary Endpoint
Reconstructions of the fiber tracts

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
82 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Reconstructions of the fiber tracts

Time Frame: 5.5 years

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

Secondary Outcomes

  • Scores at neuropsychological evaluation(5.5 years)
  • Number of subjects included in the database(5.5 years)
  • In vivo MRI measures obtained from DWI(5.5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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