Developmental DyslexiaPHR04-CH/DYSNCT00254644
Morphofunctional Imaging and Developmental Dyslexia
An observational study of Developmental Dyslexia, run by University Hospital, Tours at 1 site in France.
Trial summary
Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Morphological and functional MRI
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Feb 2008
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: This is a prospective study including 15 right-handed male subjects, aged 18 to 35 years, carrying a developmental dyslexia and 15 control subjects handed the same sex. We chose to include only male subjects to obtain a homogeneous population and to avoid the problem of a functional organization differs according to gender.
Who may be able to join
- Developmental dyslexia according to Critchley.
- Normal performance intelligence quotient (PIQ)
- Age: 18-35 years
- Sex: Male
- Right handed
- No hearing deficit.
Who cannot join
- No head injury
- No attention deficit hyperactivity disorder (ADHD)
Trial locations and contacts
1 site in 1 country.
About this study
Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.
- Conditions
- Developmental Dyslexia
- Being tested
- Morphological and functional MRI
- Keywords
- phonological treatment, language, fMRI
- Medical subject headings
- Dyslexia, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphological and functional MRIProcedure or surgery
one time
| Study group | Role | What they receive |
|---|---|---|
| Dyslexia | adults from 18-35 ans. Receives: Procedure: Morphological and functional MRI | |
| Control | adults from 18-35 ans. Receives: Procedure: Morphological and functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness
The average cortical thickness maps of healthy subjects and dyslexic will be compared hemisphere by hemisphere. This will identify whether there are cortical areas including cortical thickness differed significantly between normal and dyslexic.ts of different ages
Measured: 2 years
Secondary outcomes (1)
Average cortical thickness
For each group, cortical thickness maps of average left and right hemispheres are compared. This will identify whether there is an asymmetry left / right in terms of cortical thickness in normal subjects and dyslexic.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DyslexiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique Bonnet-Brilhault, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254644
- Sponsor's protocol ID
- PHRR04-CH/DYS
- Acronym
- PHR04-CH/DYS
- Status last verified
- May 2011
- First submitted
- 15 Nov 2005
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphofunctional Imaging and Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT00254644
- Acronym / sponsor ID
- PHR04-CH/DYS / PHRR04-CH/DYS
- Conditions
- Developmental Dyslexia
- Keywords
- phonological treatment, language, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Nov 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.
Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyslexia | – | Procedure: Morphological and functional MRIadults from 18-35 ans. |
| Control | – | Procedure: Morphological and functional MRIadults from 18-35 ans. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a prospective study including 15 right-handed male subjects, aged 18 to 35 years, carrying a developmental dyslexia and 15 control subjects handed the same sex. We chose to include only male subjects to obtain a homogeneous population and to avoid the problem of a functional organization differs according to gender.
Key inclusion criteria (6 listed)
- Developmental dyslexia according to Critchley.
- Normal performance intelligence quotient (PIQ)
- Age: 18-35 years
- Sex: Male
- Right handed
Key exclusion criteria (2 listed)
- No head injury
- No attention deficit hyperactivity disorder (ADHD)
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 |
|---|---|---|
| Morphological and functional MRIone time | Procedure or surgery | Control, Dyslexia |
Primary outcome
Cortical thickness
Time frame: 2 years
The average cortical thickness maps of healthy subjects and dyslexic will be compared hemisphere by hemisphere. This will identify whether there are cortical areas including cortical thickness differed significantly between normal and dyslexic.ts of different ages
1 secondary outcome
Average cortical thickness
Time frame: 2 years
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 16 Jan 2017.
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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.
Frédérique Bonnet-Brilhault principal investigator
CHU 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 Developmental Dyslexia, 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 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: finished, as of the sponsor's last update on 16 Jan 2017. 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?
Cortical thickness (time frame: 2 years). 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 16 Jan 2017.