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Effect of Normal Aging on Language Processing (SEMVIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189460
Recruitment Status : Terminated (Not enough subjects)
First Posted : July 14, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date July 3, 2014
First Posted Date July 14, 2014
Last Update Posted Date October 12, 2018
Study Start Date July 2014
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2014)
  • Blood Oxygen Level Dependent functional MRI [ Time Frame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year. ]
    We use 3 functional tasks using block paradigm: Object naming, Verbal generation and semantic judgment, to elicit BOLD response using fMRI in order to compare functional activation patterns between subjects. We also use hypercapnic challenge to elicit BOLD response in order to obtain Cerebral Vascular Reactivity properties of subjects.
  • Anatomical MRI [ Time Frame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year. ]
    We use Voxel Based Morphometry to compare cortical volume (grey matter) between subjects. We also use tractography Diffusion Tensor Imaging to compare white matter properties between subjects.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Normal Aging on Language Processing
Official Title Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.
Brief Summary The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

60 healthy adults will participate to the study. There will be 3 age groups: 30-50, 50-70, > 70 years. Ech group will contain 20 volunteers.

The volunteers are recruited by means of ads on Laboratory websites and Universities.

Condition Cognition
Intervention Not Provided
Study Groups/Cohorts Healthy adults
20 young adults aged between 30 and 50 years old. 20 middle aged adults aged between 50 and 70 years old. 20 older adults of 70 years old and more.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 9, 2018)
33
Original Estimated Enrollment
 (submitted: July 10, 2014)
60
Actual Study Completion Date July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age of 30 years and above
  • Right handed
  • French native speakers
  • Affiliation to French social security (Sécurité Sociale)
  • Medical interview
  • Consent form signed

Exclusion Criteria:

  • Cerebral or respiratory pathologies
  • Any MRI contrindication
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02189460
Other Study ID Numbers 2014-AZ00569-38
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Alexandre Krainik, Professor Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.
Study Director: Monica Baciu, Professor Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.
PRS Account University Hospital, Grenoble
Verification Date October 2018