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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

France1 site
  • University Hospital

    Tours, 37044

Other trials in France

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.

  1. First posted18 Oct 2005 (estimated)

Resources

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
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

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.

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