Synaptic Plasticity Imaging With Diffusion MRI

Brain Aging Clinical Trial

Official title:

Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01686516
• Other study ID #: C10-58
• Secondary ID: 2011-A00034-37
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2012
• Last updated: September 17, 2012
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Renaud NICOLAS, PhD
• Phone: (+33)7 77 05 76 75
• Email: rnd.nicolas[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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 (venography, tractography by diffusion) features in young and aged subjects.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ages 20-30 years

• 60-80 years

Exclusion Criteria:

• psychological or organic trouble

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Aging

Locations

Country	Name	City	State
France	Inserm U 825	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France,