22q11.2 Deletion SyndromeARITH22NCT04373226
Arithmetic Abilities in Children With 22q11.2DS
A study testing Magnitude comparison tasks and neuropsychological testing in people with 22q11.2 Deletion Syndrome, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The study ARITH22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- 22q11.2 Deletion Syndrome
- What is being tested?
- Magnitude comparison tasks and neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2020to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 11 years old
- French language
Who cannot join
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- 22q11.2 Deletion Syndrome
- Being tested
- Magnitude comparison tasks and neuropsychological testing
- Keywords
- 22q11.2 deletion syndrome, arithmetic, magnitude representation, children
- Medical subject headings
- DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnitude comparison tasks and neuropsychological testingBehavioural
neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)
| Study group | Role | What they receive |
|---|---|---|
| 22q11.2DS | Experimental | Children aged from 4 to 11 years old with 22q11.2 deletion syndrome Receives: Behavioral: Magnitude comparison tasks and neuropsychological testing |
| NON22q11.2DS | Active comparator | Children aged from 4 to 11 years old without developmental disease Receives: Behavioral: Magnitude comparison tasks and neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of impaired scaled score
percentage of impaired scaled score at ZAREKI-R
Measured: single day
Secondary outcomes (2)
Percentage of correct responses
percentage of correct responses in magnitude comparisons tasks
Measured: single day
Mean reaction time
mean reaction time in magnitude comparison tasks
Measured: single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start16 Sep 2020
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Why it stopped: Departure of the investigator who was recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 22q11.2 Deletion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric study with two parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DEMILY, MD PH, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373226
- Sponsor's protocol ID
- 2020-A00102-37
- Acronym
- ARITH22
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2020
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38961462
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Arithmetic Abilities of Children With 22q11.2 Deletion Syndrome Aged From 4 to 11 Years Old
- ClinicalTrials.gov ID
- NCT04373226
- Acronym / sponsor ID
- ARITH22 / 2020-A00102-37
- Conditions
- 22q11.2 Deletion Syndrome
- Keywords
- 22q11.2 deletion syndrome, arithmetic, magnitude representation, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the investigator who was recruiting subjects
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric study with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| 22q11.2DS | Experimental | Behavioral: Magnitude comparison tasks and neuropsychological testingChildren aged from 4 to 11 years old with 22q11.2 deletion syndrome |
| NON22q11.2DS | Active comparator | Behavioral: Magnitude comparison tasks and neuropsychological testingChildren aged from 4 to 11 years old without developmental disease |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 11 years old
- French language
Key exclusion criteria (2 listed)
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnitude comparison tasks and neuropsychological testingneuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial) | Behavioural | 22q11.2DS, NON22q11.2DS |
Primary outcome
Percentage of impaired scaled score
Time frame: single day
percentage of impaired scaled score at ZAREKI-R
2 secondary outcomes
Percentage of correct responses
Time frame: single day
Mean reaction time
Time frame: single day
Results and safety
The study was stopped early (reason given: Departure of the investigator who was recruiting subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 38961462Favre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline DEMILY, MD PH principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnitude comparison tasks and neuropsychological testing in people with 22q11.2 Deletion Syndrome, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Departure of the investigator who was recruiting subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of impaired scaled score (time frame: single day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.