Developmental Dyslexia and Functional Maturation of Audit... | NCT00245804

Studies
Developmental Dyslexia and Functional Maturation of Auditory Cortex

NCT00245804

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Jun 30, 2010Estimated

Enrollment

Phase

Not provided

Conditions

Developmental Reading Disorder
Dyslexia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Oct 26, 2005

First Submission Date that Met QC Criteria

Oct 26, 2005

First Posted Date

Oct 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2010

Last Update Posted Date

Jun 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult dyslexia		Adult dyslexia
Minor-Dyslexia		Minor-Dyslexia
Adult-Control		Adult-Control
Minor-Control		Minor-Control

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age (8-10 years ; 11-17 years ; 18-25 years developmental reading disorders (developmental dyslexia) criteria according to Critchley (1970) PIQ > 85 No auditory deficit No psychosis -

Exclusion Criteria:

PIQ < 85 Epilepsy ADHD Stroke, head injury

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Patients with developmental reading disorders from 8 to 25 jears. Control groupes with healthy people in de same age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline Hommet	University Hospital of Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Tours		Tours		37044	France

Condition Browse Module

MeSH Terms

ID	Term
D004410	Dyslexia

Ancestor Terms

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided