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Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice (NHB)

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ClinicalTrials.gov Identifier: NCT04934033
Recruitment Status : Not yet recruiting
First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including functional and diffusion sequences, together with a language and cognitive assessment. This will make it possible to compare the data with those obtained in the same center and under the same examination conditions in brain tumor patients. The investigators seek to evidence general patterns of cerebral morphological and functional changes, correlated with behavioural scores, in brain-damaged patients.

Condition or disease Intervention/treatment Phase
Healthy Subjects Other: Neurological assessments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Nice Healthy Brain - Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy volunteers
The participants will constitue a cohort of healthy volunteers, they will have a MRI, and language and cognitive assessment.
Other: Neurological assessments
The participants will have a MRI, and language and cognitive assessments.




Primary Outcome Measures :
  1. Number of cerebral MRI [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • cerebral and psychiatric healthy volunteer
  • agreeing to participate in this research
  • 30 and 50 years old or between 60 and 75 years old

Exclusion Criteria:

  • contra-indication to MRI
  • refusal of patient participation
  • pregnant, lactating or parturient women
  • vulnerable people

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04934033


Contacts
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Contact: Laetitia Imbert de la Phalecque 0492034819 ext +33 imbertdelaphalecque.l@chu-nice.fr

Locations
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France
University Hospital of Nice
Nice, France, 06001
Contact: Laetitia Imbert de la Phalecque    0492034819 ext +33    imbertdelaphalecque.l@chu-nice.fr   
Principal Investigator: Fabien Almairac, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04934033    
Other Study ID Numbers: 21-AOI-01
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No