Brain AgingNCT01686516
Synaptic Plasticity Imaging With Diffusion MRI
An observational study of Brain Aging, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical… Read more about this study
- Who is it for?
- Ages 20 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Aging
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2011to 19 Sep 2012
- Phase
- Observational
- 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 20 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: population free of any psychological or organic troubles, with no metal inclusions for MRI convenience.
Who may be able to join
- ages 20-30 years
- 60-80 years
Who cannot join
- psychological or organic trouble
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI
Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.
Read the detailed description
This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain :
- functional imaging using DWI and BOLD
- anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used anatomical imaging like T1 maps and susceptibility-based maps.
First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was explored to obtain activation of brain following visual stimulations. These modality was compared to BOLD and anatomical venography.
The DWI exams for anatomical (tractography) used both high angular resolution directional diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain precise knowledge about tissue microstructure.
Study was approved by the National French Institute of Health and by french organism for biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to aged healthy people (60-80 years).
Then, anatomical studies are devoted to obtain microstructures information about brain areas that are changed with age, and to validate fully the feasibility of the DfMRI approach.
- Conditions
- Brain Aging
- Keywords
- age, microstructure, diffusion MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of synaptic plasticity using diffusion decline MRI
Diffusion decline imaging involves acquiring diffusion-weighted images (S image) by incrementing the b-factor (or diffusion weighting factor) over the course of several measurements; One measurement is taken for b = 0 s/mm² and provides image S0.
This signal is obtained for each pixel of the S image, divided by the S0 image, producing an S/S0 image weighted by diffusion.
Measured: To a maximum of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start5 Dec 2011
- Primary completion19 Sep 2012
- Study completion19 Sep 2012
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 Brain AgingStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686516
- Sponsor's protocol ID
- C10-58
- Other IDs
- 2011-A00034-37
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2012
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Nicolas R, Sibon I, Hiba B. Accuracies and Contrasts of Models of the Diffusion-Weighted-Dependent Attenuation of the MRI Signal at Intermediate b-values. Magn Reson Insights. 2015 Jun 11;8:11-21. doi: 10.4137/MRI.S25301. eCollection 2015.
PubMed 26106263
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI
- ClinicalTrials.gov ID
- NCT01686516
- Acronym / sponsor ID
- C10-58
- Conditions
- Brain Aging
- Keywords
- age, microstructure, diffusion MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 19 Sep 2012 (actual)
- Study completion
- 19 Sep 2012 (actual)
- First posted
- 18 Sep 2012 (estimated)
- 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.
Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.
Detailed description
This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain :
- functional imaging using DWI and BOLD
- anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used anatomical imaging like T1 maps and susceptibility-based maps.
First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was explored to obtain activation of brain following visual stimulations. These modality was compared to BOLD and anatomical venography.
The DWI exams for anatomical (tractography) used both high angular resolution directional diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain precise knowledge about tissue microstructure.
Study was approved by the National French Institute of Health and by french organism for biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to aged healthy people (60-80 years).
Then, anatomical studies are devoted to obtain microstructures information about brain areas that are changed with age, and to validate fully the feasibility of the DfMRI approach.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- population free of any psychological or organic troubles, with no metal inclusions for MRI convenience.
Key inclusion criteria (2 listed)
- ages 20-30 years
- 60-80 years
Key exclusion criteria (1 listed)
- psychological or organic trouble
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of synaptic plasticity using diffusion decline MRI
Time frame: To a maximum of 30 days
Diffusion decline imaging involves acquiring diffusion-weighted images (S image) by incrementing the b-factor (or diffusion weighting factor) over the course of several measurements; One measurement is taken for b = 0 s/mm² and provides image S0. This signal is obtained for each pixel of the S image, divided by the S0 image, producing an S/S0 image weighted by diffusion.
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 22 Jul 2026.
- Results publication: PubMed 26106263Nicolas R, Sibon I, Hiba B. Accuracies and Contrasts of Models of the Diffusion-Weighted-Dependent Attenuation of the MRI Signal at Intermediate b-values. Magn Reson Insights. 2015 Jun 11;8:11-21. doi: 10.4137/MRI.S25301. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aging, run by Institut National de la Santé Et de la Recherche Médicale, France 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 1 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 22 Jul 2026. 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. 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?
Assessment of synaptic plasticity using diffusion decline MRI (time frame: To a maximum of 30 days). 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 NCT01686516, 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 22 Jul 2026.