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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03109275
Other study ID # 69HCL16_0687
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2016
Est. completion date February 14, 2020

Study information

Verified date April 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this project is to develop a new model to characterize brain connectivity and its changes with aging. This characterization will be based on new sensitive and specific markers, allowing a better understanding of structural and functional brain networks. To this end, two complementary MRI methods will be developed: 1) Resting-state functional MRI (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and reconstruct fiber tractography of patient's brains. In combination with conventional MRI, both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of cortical regions, so- called "Connectome". Once generated, brain networks will be quantified through numerous graph metrics, such as graph density, global efficiency and assortativity (etc.), reflecting the organization and topology of subjects' connectivity with aging.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 14, 2020
Est. primary completion date February 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Volunteers (Men and women) aged between 18 and 50 years - No neurological or psychiatric diseases Exclusion Criteria: - MRI contraindications - Pregnant women or nursing women - Persons under guardianship or any other administrative or deprivation of liberty or of right

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Single complete MRI intervention
MRI examination will comprise conventional T1 and FLAIR sequences, and advanced sequences such as rs-fMRI and High angular resolution MRI (HARDI).

Locations

Country Name City State
France CH le Vinatier Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional and structural connectivity MRI marker : resting-state fMRI Functional connectivity of grey matter (GM) using resting-state fMRI End of study (one year)
Primary Functional and structural connectivity MRI marker : Functional connectivity Graph-theory methods analysis of functional connectivity of grey matter End of study (one year)
Primary Functional and structural connectivity MRI marker : Diffusion tensor Structural connectivity of white matter (WM) fiber bundles measured by diffusion tensor imaging End of study (one year)
Primary Functional and structural connectivity MRI marker : Structural connectivity Graph-theory methods analysis of Structural connectivity of white matter (WM) fiber End of study (one year)
Primary Functional and structural connectivity MRI marker : SPM software Cortical and subcortical grey matter (GM) volumes using the SPM software End of study (one year)
Secondary Metrics of functional connectivity Calculation of functional connectivity metrics using graphs theory methods End of study (one year)
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