CognitionSEMVIENCT02189460
Effect of Normal Aging on Language Processing
An observational study of Cognition, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age of 30 years and above
- Right handed
- French native speakers
- Affiliation to French social security (Sécurité Sociale)
- Medical interview
- Consent form signed
Who cannot join
- Cerebral or respiratory pathologies
- Any MRI contrindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.
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.
- Conditions
- Cognition
- Keywords
- Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent functional MRI
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.
Measured: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
Anatomical MRI
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.
Measured: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Not enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Krainik, Professor, Principal investigator, Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.Monica Baciu, Professor, Study director, Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189460
- Sponsor's protocol ID
- 2014-AZ00569-38
- Acronym
- SEMVIE
- Status last verified
- Oct 2018
- First submitted
- 3 Jul 2014
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.
- ClinicalTrials.gov ID
- NCT02189460
- Acronym / sponsor ID
- SEMVIE / 2014-AZ00569-38
- Conditions
- Cognition
- Keywords
- Cognition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough subjects
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Jul 2014 (estimated)
- 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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age of 30 years and above
- Right handed
- French native speakers
- Affiliation to French social security (Sécurité Sociale)
- Medical interview
Key exclusion criteria (2 listed)
- Cerebral or respiratory pathologies
- Any MRI contrindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Not enough subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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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.
Alexandre Krainik, Professor principal investigator
Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.
Monica Baciu, Professor study director
Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by University Hospital, Grenoble 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Oct 2018. 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 was stopped early (reason given: Not enough subjects). Results are not available in the source record.
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?
Blood Oxygen Level Dependent functional MRI (time frame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.). The study lists 2 primary outcomes in all. 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 12 Oct 2018.