NCT04934033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

July 5, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

June 9, 2021

Last Update Submit

July 1, 2022

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Number of cerebral MRI

    6 months

Study Arms (1)

Healthy volunteers

OTHER

The participants will constitue a cohort of healthy volunteers, they will have a MRI, and language and cognitive assessment.

Other: Neurological assessments

Interventions

Neurological assessmentsOTHER

The participants will have a MRI, and language and cognitive assessments.

Healthy volunteers

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06001, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 22, 2021

Study Start

August 23, 2021

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

July 5, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)