HealthyAGE-CONNECTNCT03109275
Connectome Characterization With Aging
A study testing Single complete MRI intervention in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single complete MRI intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2016to 14 Feb 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers (Men and women) aged between 18 and 50 years
- No neurological or psychiatric diseases
Who cannot join
- MRI contraindications
- Pregnant women or nursing women
- Persons under guardianship or any other administrative or deprivation of liberty or of right
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Single complete MRI intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Single MRI examination | Active comparator | 40 subjects will benefit from a full MRI Receives: 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). Receives: Other: Single complete MRI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and structural connectivity MRI marker : resting-state fMRI
Functional connectivity of grey matter (GM) using resting-state fMRI
Measured: End of study (one year)
Functional and structural connectivity MRI marker : Functional connectivity
Graph-theory methods analysis of functional connectivity of grey matter
Measured: 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
Measured: 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
Measured: End of study (one year)
Functional and structural connectivity MRI marker : SPM software
Cortical and subcortical grey matter (GM) volumes using the SPM software
Measured: End of study (one year)
Secondary outcomes (1)
Metrics of functional connectivity
Calculation of functional connectivity metrics using graphs theory methods
Measured: End of study (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start22 Jan 2016
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
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 HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Mouchet-Mages, MD, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109275
- Sponsor's protocol ID
- 69HCL16_0687
- Acronym
- AGE-CONNECT
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2017
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38848246
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectome Characterization With Aging Using Functional and Structural MRI
- ClinicalTrials.gov ID
- NCT03109275
- Acronym / sponsor ID
- AGE-CONNECT / 69HCL16_0687
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single MRI examination | Active comparator | Other: Single complete MRI intervention40 subjects will benefit from a full MRI |
| Reproducibility study | Sham comparator | Other: Single complete MRI intervention10 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteers (Men and women) aged between 18 and 50 years
- No neurological or psychiatric diseases
Key exclusion criteria (3 listed)
- MRI contraindications
- Pregnant women or nursing women
- Persons under guardianship or any other administrative or deprivation of liberty or of right
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 |
|---|---|---|
| Single complete MRI interventionMRI examination will comprise conventional T1 and FLAIR sequences, and advanced sequences such as rs-fMRI and High angular resolution MRI (HARDI). | Other | Reproducibility study, Single MRI examination |
Primary outcome
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
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
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
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
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
1 secondary outcome
Metrics of functional connectivity
Time frame: End of study (one year)
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 2 Oct 2025.
- Results publication: PubMed 38848246Nusbaum 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.
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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.
Sabine Mouchet-Mages, MD principal investigator
CH le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single complete MRI intervention in people with Healthy, run by Hospices Civils de Lyon at 1 site 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 2 inclusion and 3 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Functional and structural connectivity MRI marker : resting-state fMRI (time frame: End of study (one year)). The study lists 5 primary outcomes in all. 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 NCT03109275, 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 2 Oct 2025.