In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- 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)