NCT02455284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

5.3 years

First QC Date

May 12, 2015

Last Update Submit

December 23, 2025

Conditions

Neurological Diseases

Keywords

MRITractographywhitephysiologyanalysismattertracts

Outcome Measures

Primary Outcomes (1)

  • Reconstructions of the fiber tracts

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

    5.5 years

Secondary Outcomes (3)

  • Number of subjects included in the database

    5.5 years

  • Scores at neuropsychological evaluation

    5.5 years

  • In vivo MRI measures obtained from DWI

    5.5 years

Study Arms (1)

Healthy subjects

EXPERIMENTAL

MRI and neuropsychological evaluation

Device: MRI

Interventions

MRIDEVICE

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

Healthy subjects

Eligibility Criteria

Age82 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital of Amiens

Amiens, 80054, France

Location

University Hospital of Angers

Angers, 49033, France

Location

University Hospital of Brest

Brest, 29609, France

Location

Hospital of Charpennes - Lyon

Lyon, 69000, France

Location

University Hospital of Nancy

Nancy, 54511, France

Location

University Hospital of Rennes

Rennes, 35033, France

Location

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (1)

  • Sizaret E, Brachet M, Launay A, Destrieux C, Zemmoura I, Angel L; FIBRATLAS Consortium. Norms for neuropsychological tests in cognitively healthy French oldest old adults. J Int Neuropsychol Soc. 2024 Nov;30(9):841-855. doi: 10.1017/S1355617724000390. Epub 2024 Sep 18.

    PMID: 39291410RESULT

Study Officials

  • Christophe DESTRIEUX, PhD

    University Hospital of Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 27, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

FR(7)