Back to resultsArithmetic Abilities in Children With 22q11.2DS (ARITH22)
Primary Purpose
22q11.2 Deletion Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnitude comparison tasks and neuropsychological testing
Sponsored by
About this trial
This is an interventional basic science trial for 22q11.2 Deletion Syndrome focused on measuring 22q11.2 deletion syndrome, arithmetic, magnitude representation, children
Eligibility Criteria
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
Sites / Locations
- Hopital VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
22q11.2DS
NON22q11.2DS
Arm Description
Children aged from 4 to 11 years old with 22q11.2 deletion syndrome
Children aged from 4 to 11 years old without developmental disease
Outcomes
Primary Outcome Measures
Percentage of impaired scaled score
percentage of impaired scaled score at ZAREKI-R
Secondary Outcome Measures
Percentage of correct responses
percentage of correct responses in magnitude comparisons tasks
Mean reaction time
mean reaction time in magnitude comparison tasks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04373226
Brief Title
Arithmetic Abilities in Children With 22q11.2DS
Acronym
ARITH22
Official Title
Study of Arithmetic Abilities of Children With 22q11.2 Deletion Syndrome Aged From 4 to 11 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
22q11.2 Deletion Syndrome
Keywords
22q11.2 deletion syndrome, arithmetic, magnitude representation, children
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric study with two parallel groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
22q11.2DS
Arm Type
Experimental
Arm Description
Children aged from 4 to 11 years old with 22q11.2 deletion syndrome
Arm Title
NON22q11.2DS
Arm Type
Active Comparator
Arm Description
Children aged from 4 to 11 years old without developmental disease
Intervention Type
Behavioral
Intervention Name(s)
Magnitude comparison tasks and neuropsychological testing
Intervention Description
neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)
Primary Outcome Measure Information:
Title
Percentage of impaired scaled score
Description
percentage of impaired scaled score at ZAREKI-R
Time Frame
single day
Secondary Outcome Measure Information:
Title
Percentage of correct responses
Description
percentage of correct responses in magnitude comparisons tasks
Time Frame
single day
Title
Mean reaction time
Description
mean reaction time in magnitude comparison tasks
Time Frame
single day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline DEMILY, MD PH
Phone
0450915163
Ext
+33
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie FAVRE, MD
Phone
0450915163
Ext
+33
Email
emilie.favre@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DEMILY, MD PH
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DEMILY MD CAROLINE, PH
Phone
0033437915163
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Arithmetic Abilities in Children With 22q11.2DS
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