Neurological DiseasesFIBRATLASNCT02455284
In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
A study testing MRI in people with Neurological Diseases, run by University Hospital, Tours at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 82 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurological Diseases
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 7 sitesFrance
- Study dates
- Oct 2015to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 82 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Diagnosis on MRI of brain lesions, excepted common age-related changes
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
University Hospital of Amiens
Amiens, 80054
University Hospital of Angers
Angers, 49033
University Hospital of Brest
Brest, 29609
Hospital of Charpennes - Lyon
Lyon, 69000
University Hospital of Nancy
Nancy, 54511
University Hospital of Rennes
Rennes, 35033
University Hospital of Tours
Tours, 37044
About this study
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.
- Conditions
- Neurological Diseases
- Being tested
- MRI
- Keywords
- MRI, Tractography, white, physiology, analysis, matter, tracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
In vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | MRI and neuropsychological evaluation Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstructions of the fiber tracts
similarity indices, such as modified Haussdorf distance, measured on MRI images
Measured: 5.5 years
Secondary outcomes (3)
Number of subjects included in the database
Number of subjects included in the database
Measured: 5.5 years
Scores at neuropsychological evaluation
Scores at neuropsychological evaluation
Measured: 5.5 years
In vivo MRI measures obtained from DWI
In vivo MRI measures obtained from DWI
Measured: 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurological DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DESTRIEUX, PhD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455284
- Sponsor's protocol ID
- ANR 14 - CD / FIBRATLAS
- Acronym
- FIBRATLAS
- Status last verified
- Dec 2025
- First submitted
- 12 May 2015
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39291410
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
- ClinicalTrials.gov ID
- NCT02455284
- Acronym / sponsor ID
- FIBRATLAS / ANR 14 - CD / FIBRATLAS
- Conditions
- Neurological Diseases
- Keywords
- MRI, Tractography, white, physiology, analysis, matter, tracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: MRIMRI and neuropsychological evaluation |
Who may qualify
- Ages
- 82 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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),
Key exclusion criteria (1 listed)
- Diagnosis on MRI of brain lesions, excepted common age-related changes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIIn vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images | Device | Healthy subjects |
Primary outcome
Reconstructions of the fiber tracts
Time frame: 5.5 years
similarity indices, such as modified Haussdorf distance, measured on MRI images
3 secondary outcomes
Number of subjects included in the database
Time frame: 5.5 years
Scores at neuropsychological evaluation
Time frame: 5.5 years
In vivo MRI measures obtained from DWI
Time frame: 5.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 39291410Sizaret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe DESTRIEUX, PhD principal investigator
University Hospital of Tours
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Neurological Diseases, run by University Hospital, Tours at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstructions of the fiber tracts (time frame: 5.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.