Connectome Characterization With Aging (AGE-CONNECT)

Connectome Characterization With Aging Using Functional and Structural MRI

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Single complete MRI intervention

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • CH Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Single MRI examination; 40 subjects will benefit from a full MRI	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).
SHAM_COMPARATOR: Reproducibility study; 10 subjects will benefit from the realization of 3 MRI. An MRI examination performed at the time of inclusion and then an examination, at 3 months and at 9 months (ie 3 examinations per subject).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional and structural connectivity MRI marker : resting-state fMRI	Functional connectivity of grey matter (GM) using resting-state fMRI	End of study (one year)
Functional and structural connectivity MRI marker : Functional connectivity	Graph-theory methods analysis of functional connectivity of grey matter	End of study (one year)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metrics of functional connectivity	Calculation of functional connectivity metrics using graphs theory methods	End of study (one year)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sabine Mouchet-Mages, MD, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2016
• Primary Completion (ACTUAL): February 14, 2020
• Study Completion (ACTUAL): February 14, 2020

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL16_0687

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No