Connectome Characterization With Aging (AGE-CONNECT)

September 29, 2025 updated by: Hospices Civils de Lyon

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
Time Frame: End of study (one year)
Functional connectivity of grey matter (GM) using resting-state fMRI
End of study (one year)
Functional and structural connectivity MRI marker : Functional connectivity
Time Frame: End of study (one year)
Graph-theory methods analysis of functional connectivity of grey matter
End of study (one year)
Functional and structural connectivity MRI marker : Diffusion tensor
Time Frame: End of study (one year)
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
Time Frame: End of study (one year)
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
Time Frame: End of study (one year)
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
Time Frame: End of study (one year)
Calculation of functional connectivity metrics using graphs theory methods
End of study (one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sabine Mouchet-Mages, MD, CH Le Vinatier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL16_0687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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