NCT03109275

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 22, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

March 1, 2017

Last Update Submit

September 29, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Metrics of functional connectivity

    End of study (one year)

Study Arms (2)

Single MRI examination

ACTIVE COMPARATOR

40 subjects will benefit from a full MRI

Other: Single complete MRI intervention

Reproducibility study

SHAM COMPARATOR

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

Interventions

Single complete MRI interventionOTHER

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

Reproducibility studySingle MRI examination

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers (Men and women) aged between 18 and 50 years
  • No neurological or psychiatric diseases

You may not qualify if:

  • MRI contraindications
  • Pregnant women or nursing women
  • Persons under guardianship or any other administrative or deprivation of liberty or of right

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH le Vinatier

Bron, 69500, France

Location

Related Publications (1)

  • Nusbaum F, Hannoun S, Barile B, Suprano I, Mouchet S, Sappey-Marinier D. Personal Income Performance Correlates with Brain Structural Network Modularity but Not Intelligence Quotient. Brain Connect. 2024 Jun;14(5):284-293. doi: 10.1089/brain.2023.0077. Epub 2024 Jun 7.

    PMID: 38848246BACKGROUND

Study Officials

  • Sabine Mouchet-Mages, MD

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

April 12, 2017

Study Start

January 22, 2016

Primary Completion

February 14, 2020

Study Completion

February 14, 2020

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)