ARITH22: Arithmetic Abilities in Children With 22q11.2DS

Sponsor

Hôpital le Vinatier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04373226

Collaborator

(none)

120

Enrollment

Location

Arms

37.1

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
22q11.2 Deletion Syndrome	Behavioral: Magnitude comparison tasks and neuropsychological testing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Monocentric study with two parallel groupsMonocentric study with two parallel groups

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 16, 2020

Anticipated Primary Completion Date :

Jul 20, 2023

Anticipated Study Completion Date :

Oct 20, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Percentage of impaired scaled score [single day]
percentage of impaired scaled score at ZAREKI-R

Secondary Outcome Measures

Percentage of correct responses [single day]
percentage of correct responses in magnitude comparisons tasks
Mean reaction time [single day]
mean reaction time in magnitude comparison tasks

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Vinatier	Lyon	Rhone Alpes	France	69678

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hôpital le Vinatier

ClinicalTrials.gov Identifier:

NCT04373226

Other Study ID Numbers:

2020-A00102-37

First Posted:

May 4, 2020

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Hôpital le Vinatier

22q11.2 deletion syndrome

arithmetic

magnitude representation

children

Additional relevant MeSH terms:

DiGeorge Syndrome

Syndrome

Study Results

No Results Posted as of Jan 27, 2022