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Prediction and Intervention in Developmental Dyslexia (LEXI)

Primary Purpose

Developmental Dyslexia

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Computerized reading training
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Dyslexia focused on measuring Electroencephalography (EEG), Magnetic Resonance Imaging (MRI), Multimodal Neuroimaging, Development, Prediction, Intervention

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria for all groups:

  • Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) >=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
  • Additional criteria for subgroups:
  • Recruitment of preschoolers (aged 5.5-7.5 years):
  • Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
  • Recruitment of children in first grade (aged 6.5-8.5years):
  • Children showing impairments in learning to read (first/second grade).
  • Adults (aged 20-40 years):
  • Healthy, normal reading

Exclusion Criteria for all groups:

  • MRI contraindications
  • No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.

Sites / Locations

  • University Clinics for Child and Adolescent Psychiatry, University of ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Computerized reading training first

Waiting Control First

Arm Description

Cross-over design: group first receives the intervention

Cross-over design: group first serves as waiting control

Outcomes

Primary Outcome Measures

Changes in reading and spelling performance
Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training

Secondary Outcome Measures

Developmental and training induced changes in functional brain activation and brain structure
Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training
Accuracy of prediction on reading performance outcome
Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures. Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)

Full Information

First Posted
August 8, 2014
Last Updated
August 13, 2014
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02217696
Brief Title
Prediction and Intervention in Developmental Dyslexia
Acronym
LEXI
Official Title
Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
Keywords
Electroencephalography (EEG), Magnetic Resonance Imaging (MRI), Multimodal Neuroimaging, Development, Prediction, Intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerized reading training first
Arm Type
Experimental
Arm Description
Cross-over design: group first receives the intervention
Arm Title
Waiting Control First
Arm Type
Experimental
Arm Description
Cross-over design: group first serves as waiting control
Intervention Type
Other
Intervention Name(s)
Computerized reading training
Primary Outcome Measure Information:
Title
Changes in reading and spelling performance
Description
Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training
Time Frame
Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months
Secondary Outcome Measure Information:
Title
Developmental and training induced changes in functional brain activation and brain structure
Description
Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training
Time Frame
Participants will be tested after an expected average of 8, 12 and 16 months
Title
Accuracy of prediction on reading performance outcome
Description
Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures. Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)
Time Frame
Participants will be tested at T1 and on average 8 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for all groups: Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) >=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments) Additional criteria for subgroups: Recruitment of preschoolers (aged 5.5-7.5 years): Healthy children with increased risk for developmental dyslexia in their second year at kindergarten Recruitment of children in first grade (aged 6.5-8.5years): Children showing impairments in learning to read (first/second grade). Adults (aged 20-40 years): Healthy, normal reading Exclusion Criteria for all groups: MRI contraindications No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Brem, PhD
Phone
+41 43 499 2760
Email
sbrem@kjpd.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Brem, PhD
Organizational Affiliation
University Clinics for Child and Adolescent Psychiatry, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinics for Child and Adolescent Psychiatry, University of Zurich
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Brem, PhD

12. IPD Sharing Statement

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Prediction and Intervention in Developmental Dyslexia

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