Arithmetic Abilities in Children With 22q11.2DS (ARITH22)

January 26, 2022 updated by: Hôpital le Vinatier

Study of Arithmetic Abilities of Children With 22q11.2 Deletion Syndrome Aged From 4 to 11 Years Old

The study ARITH22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Children with 22q11.2 deletion syndrome often have arithmetic learning disability because of magnitude representation impairment. Previous works suggested that magnitude representation impairment could be a result of endogenous visuo-spatial attention dysfunction in 22q11.2DS. Nevertheless this relationship is still poor explored. The influence of visuo-spatial abilities on arithmetic achievement could also be modulated by developmental age. The study ARITH22 will test these hypotheses thanks to magnitude comparisons tasks, in children with 22q11.2 deletion syndrome and matched children without developmental disease.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Rhone Alpes
      • Lyon, Rhone Alpes, France, 69678
        • Recruiting
        • Hopital Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of 22q11.2 deletion syndrome or no developmental disease
  • Aged from 4 to 11 years old
  • French language

Exclusion Criteria:

  • Diagnosis of intellectual deficiency according to DSM 5 criteria
  • Drug prescribed for somatic condition that could influence cerebral functioning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 22q11.2DS
Children aged from 4 to 11 years old with 22q11.2 deletion syndrome
Behavioral: Magnitude comparison tasks and neuropsychological testing
neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)
Active Comparator: NON22q11.2DS
Children aged from 4 to 11 years old without developmental disease
Behavioral: Magnitude comparison tasks and neuropsychological testing
neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of impaired scaled score
Time Frame: single day
percentage of impaired scaled score at ZAREKI-R
single day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of correct responses
Time Frame: single day
percentage of correct responses in magnitude comparisons tasks
single day
Mean reaction time
Time Frame: single day
mean reaction time in magnitude comparison tasks
single day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Investigators

  • Principal Investigator: Caroline DEMILY, MD PH, Centre Hospitalier Le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Anticipated)

July 20, 2023

Study Completion (Anticipated)

October 20, 2023

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00102-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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