Healthy SubjectsNHBNCT04934033
Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice
A study testing Neurological assessments in people with Healthy Subjects, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Neurological assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cerebral and psychiatric healthy volunteer
- agreeing to participate in this research
- 30 and 50 years old or between 60 and 75 years old
Who cannot join
- contra-indication to MRI
- refusal of patient participation
- pregnant, lactating or parturient women
- vulnerable people
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Nice
Nice, Provence-Alpes-Côte d'Azur Region, 06001
About this study
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
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.
- Conditions
- Healthy Subjects
- Being tested
- Neurological assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological assessmentsOther
The participants will have a MRI, and language and cognitive assessments.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | The participants will constitue a cohort of healthy volunteers, they will have a MRI, and language and cognitive assessment. Receives: Other: Neurological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cerebral MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start23 Aug 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934033
- Sponsor's protocol ID
- 21-AOI-01
- Acronym
- NHB
- Status last verified
- Jul 2022
- First submitted
- 9 Jun 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04934033
- Acronym / sponsor ID
- NHB / 21-AOI-01
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Neurological assessmentsThe participants will constitue a cohort of healthy volunteers, they will have a MRI, and language and cognitive assessment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cerebral and psychiatric healthy volunteer
- agreeing to participate in this research
- 30 and 50 years old or between 60 and 75 years old
Key exclusion criteria (4 listed)
- contra-indication to MRI
- refusal of patient participation
- pregnant, lactating or parturient women
- vulnerable people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological assessmentsThe participants will have a MRI, and language and cognitive assessments. | Other | Healthy volunteers |
Primary outcome
Number of cerebral MRI
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological assessments in people with Healthy Subjects, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cerebral MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.