AgingNCT00241306
Variations of Hemispheric Lateralisation of Language Depending of Gender and Age.
An observational study of Aging, run by University Hospital, Tours at 1 site in France.
Trial summary
The purpose of this study is to determine whether gender and age modify cerebral activations during a silent word generation functional Magnetic Resonance task. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal neurological examination
- right handed (lateralization index greater or equal to 0.8)
- Extra inclusion criteria for old subjects:
- Mini Mental State > 26
- no criteria for Alzheimer's disease (DSM IV and NINCDS-ADRDA)
Who cannot join
- neurological or uncontrolled cardiovascular disease (past or present)
- contraindicate for MRI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether gender and age modify cerebral activations during a silent word generation functional Magnetic Resonance task.
Read the detailed description
Introduction : The theory of a bipolar organization of language was revised in the light of neuroimaging results and language seems to be processed in a large scale cognitive network. The organization and function of this neural network may be modified by several factors including gender and age. There is some controversy about sex differences in language according to behavioural and neuroimaging studies :
- a small but significant difference favouring females was observed for language abilities.
- a greater bi hemispheric functional Magnetic Resonance Imaging (fMRI)activation was described in females during language tasks, but Frost et al found no differences during a language comprehension task according to gender.
Age differences were mainly studied in childhood, but no consistent functional imaging data on aging are available.
Objective : To study the influence of gender and age on cortical fMRI activations during a silent semantic task.
Subjects : 48 right-handed native French-speaking subjects were included in 4 groups of 12 according to age and gender : young female (YF), Young Male (YM), Old Female (OF), and Old Male (OM). Old subjects had no Alzheimer's disease or other dementia according to their MMS score (> 26) and NINCDS-ADRDA criteria.
Method :
- fMRI : Data were collected on a 1.5 T General Electric Signa MR scanner. Functional images covered the whole brain and were scanned using a single-shot echoplanar imaging sequence (FOV : 24 cm ¡thickness : 5 mm - 64 x 64 matrix - TE : 60 ms ¡ TR : 3s ¡ flip angle : 90°). The paradigm followed a box car design and 3 periods of activation (30 s duration) alternated with 3 periods of fixation (30s duration). During the active condition subjects had to mentally generate words corresponding to the semantic category (animals, furniture, or fruit) displayed through MR-compatible special goggles.During the control condition, they were requested to concentrate on their breathing. Data were analyzed using the FSFAST package. MR data were motion corrected using AFNI and then smoothed with a FWHM of 5 mm. The voxel intensities were rescaled such that the in-brain grand mean was 1000 for all subjects. The hemodynamic response was modeled as a gamma function (delay : 2.25 s - dispersion :1.25 s). The offset and linear drift in the BOLD signal were removed by estimating those components simultaneously with the amplitude of the hemodynamic response. A t-test was then performed on the amplitude of the hemodynamic response to determine which voxels had significant paradigm-related activity.
- anatomical MR : Results were displayed on the inflated cortical surface for each subject. A group analysis was performed using a surface coordinate system and random model effect and General linear model using age and gender as regressors.
- Conditions
- Aging
- Keywords
- aging, language, gender
- Medical subject headings
- Language, Coitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Destrieux, MD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241306
- Sponsor's protocol ID
- PHRC-R2001
- Status last verified
- Jul 2005
- First submitted
- 14 Oct 2005
- Last updated
- 18 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of Hemispheric Lateralisation of Language Depending of Gender and Age.
- ClinicalTrials.gov ID
- NCT00241306
- Acronym / sponsor ID
- PHRC-R2001
- Conditions
- Aging
- Keywords
- aging, language, gender
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- First posted
- 18 Oct 2005 (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 determine whether gender and age modify cerebral activations during a silent word generation functional Magnetic Resonance task.
Detailed description
Introduction : The theory of a bipolar organization of language was revised in the light of neuroimaging results and language seems to be processed in a large scale cognitive network. The organization and function of this neural network may be modified by several factors including gender and age. There is some controversy about sex differences in language according to behavioural and neuroimaging studies :
- a small but significant difference favouring females was observed for language abilities.
- a greater bi hemispheric functional Magnetic Resonance Imaging (fMRI)activation was described in females during language tasks, but Frost et al found no differences during a language comprehension task according to gender.
Age differences were mainly studied in childhood, but no consistent functional imaging data on aging are available.
Objective : To study the influence of gender and age on cortical fMRI activations during a silent semantic task.
Subjects : 48 right-handed native French-speaking subjects were included in 4 groups of 12 according to age and gender : young female (YF), Young Male (YM), Old Female (OF), and Old Male (OM). Old subjects had no Alzheimer's disease or other dementia according to their MMS score (> 26) and NINCDS-ADRDA criteria.
Method :
- fMRI : Data were collected on a 1.5 T General Electric Signa MR scanner. Functional images covered the whole brain and were scanned using a single-shot echoplanar imaging sequence (FOV : 24 cm ¡thickness : 5 mm - 64 x 64 matrix - TE : 60 ms ¡ TR : 3s ¡ flip angle : 90°). The paradigm followed a box car design and 3 periods of activation (30 s duration) alternated with 3 periods of fixation (30s duration). During the active condition subjects had to mentally generate words corresponding to the semantic category (animals, furniture, or fruit) displayed through MR-compatible special goggles.During the control condition, they were requested to concentrate on their breathing. Data were analyzed using the FSFAST package. MR data were motion corrected using AFNI and then smoothed with a FWHM of 5 mm. The voxel intensities were rescaled such that the in-brain grand mean was 1000 for all subjects. The hemodynamic response was modeled as a gamma function (delay : 2.25 s - dispersion :1.25 s). The offset and linear drift in the BOLD signal were removed by estimating those components simultaneously with the amplitude of the hemodynamic response. A t-test was then performed on the amplitude of the hemodynamic response to determine which voxels had significant paradigm-related activity.
- anatomical MR : Results were displayed on the inflated cortical surface for each subject. A group analysis was performed using a surface coordinate system and random model effect and General linear model using age and gender as regressors.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- normal neurological examination
- right handed (lateralization index greater or equal to 0.8)
- Mini Mental State > 26
- no criteria for Alzheimer's disease (DSM IV and NINCDS-ADRDA)
Key exclusion criteria (2 listed)
- neurological or uncontrolled cardiovascular disease (past or present)
- contraindicate for MRI
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2005.
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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.
Christophe Destrieux, MD principal investigator
University Hospital of Tours
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 Aging, run by University Hospital, Tours 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 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2005. 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?
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.
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 18 Oct 2005.