Prediction and Intervention in Developmental Dyslexia

Developmental Dyslexia Clinical Trial

— LEXI  

Official title:

Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02217696
• Other study ID #: LEXI SNF32003B_141201/1
• Secondary ID: 32003B_141201/1
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2014
• Last updated: August 13, 2014
• Start date: July 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2014
• Source: University of Zurich
• Contact: Silvia Brem, PhD
• Phone: +41 43 499 2760
• Email: sbrem[@]kjpd.uzh.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

Other:
• Computerized reading training

Locations

Country	Name	City	State
Switzerland	University Clinics for Child and Adolescent Psychiatry, University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in reading and spelling performance	Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training	Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months	No
Secondary	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	Participants will be tested after an expected average of 8, 12 and 16 months	No
Secondary	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)	Participants will be tested at T1 and on average 8 months later	No