NCT04373226

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

April 30, 2020

Last Update Submit

March 4, 2025

Conditions

Keywords

22q11.2 deletion syndromearithmeticmagnitude representationchildren

Outcome Measures

Primary Outcomes (1)

  • Percentage of impaired scaled score

    percentage of impaired scaled score at ZAREKI-R

    single day

Secondary Outcomes (2)

  • Percentage of correct responses

    single day

  • Mean reaction time

    single day

Study Arms (2)

22q11.2DS

EXPERIMENTAL

Children aged from 4 to 11 years old with 22q11.2 deletion syndrome

Behavioral: Magnitude comparison tasks and neuropsychological testing

NON22q11.2DS

ACTIVE COMPARATOR

Children aged from 4 to 11 years old without developmental disease

Behavioral: Magnitude comparison tasks and neuropsychological testing

Interventions

neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)

22q11.2DSNON22q11.2DS

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

Related Publications (1)

  • Favre E, Piveteau M, Babinet MN, Demily C. Extent of magnitude representation deficit and relationship with arithmetic skills in children with 22q11.2DS. Orphanet J Rare Dis. 2024 Jul 3;19(1):250. doi: 10.1186/s13023-024-03263-1.

MeSH Terms

Conditions

DiGeorge Syndrome

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Caroline DEMILY, MD PH

    Centre Hospitalier le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Monocentric study with two parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

September 16, 2020

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations