Synaptic Plasticity Imaging With Diffusion MRI
| Tracking Information | |||||
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| First Received Date ICMJE | September 7, 2012 | ||||
| Last Updated Date | September 17, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01686516 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Synaptic Plasticity Imaging With Diffusion MRI | ||||
| Official Title ICMJE | Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI | ||||
| Brief 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 (venography, tractography by diffusion) features in young and aged subjects. |
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| Detailed Description | This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain :
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Crossover Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | population free of any psychological or organic troubles, with no metal inclusions for MRI convenience. |
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| Condition ICMJE | "Brain Aging" | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01686516 | ||||
| Other Study ID Numbers ICMJE | C10-58, 2011-A00034-37 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Study Sponsor ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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