Attention Deficit in Intellectual DisabilityEVALDINCT03878251
Outcomes Measures in Intellectual Disability
A study testing Quantitative attention evaluation criteria in intellectual disability in people with Attention Deficit in Intellectual Disability, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Attention Deficit in Intellectual Disability
- What is being tested?
- Quantitative attention evaluation criteria in intellectual disability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to 7 Jun 2022
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sex, with intellectual disability
- Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients
- Patients with more or less severe intellectual disability from various causes including Fragile X syndrome, Rett syndrome, Angelman syndrome and other etiologies of intellectual disabilities and intellectual disabilities without identified etiology
- Affiliation to a social security system own or affiliated (excluding AME)
- Presence of parents or legal representative
- Informed consent signed by parents or legal representative
Who cannot join
- Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
- Uncontrolled seizure disorder despite treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.
Read the detailed description
The aim of the study is to develop and validate quantitative interactive attention evaluation criteria by using games on touchscreen and or eye tracking in patients with intellectual disability. Tests will have to be suitable whatever severity and etiology of intellectual disability. Tests have to evaluate attention and concentration troubles in intellectual disability.Once validated, tests could be used as outcome measures in clinical trials and as cognitive reeducation tools in intellectual disability.
- Being tested
- Quantitative attention evaluation criteria in intellectual disability
- Keywords
- Intellectual disability, Attention evaluation criteria, Games on touchscreen, Eye tracking
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative attention evaluation criteria in intellectual disabilityDevice
Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
| Study group | Role | What they receive |
|---|---|---|
| X fragile syndrome patients | Other | Not described Receives: Device: Quantitative attention evaluation criteria in intellectual disability |
| Angelman syndrome patients | Other | Not described Receives: Device: Quantitative attention evaluation criteria in intellectual disability |
| Rett syndrome patients | Other | Not described Receives: Device: Quantitative attention evaluation criteria in intellectual disability |
| Patients with other genetic rare syndromes with intellectual d | Other | Not described Receives: Device: Quantitative attention evaluation criteria in intellectual disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
Test performed 1 time during a visit (1 day) can be repeated (for a maximum of 15 patients) within 3 months if an adaptation of the interactive tool is necessary
Measured: up to 3 months
Secondary outcomes (8)
Maximal reached level for each test
Measured: up to 3 months
Number of errors during the test
Measured: up to 3 months
Time to reach each level of the test
Measured: up to 3 months
Time to reach maximum level of the test
Measured: up to 3 months
Total test duration
Measured: up to 3 months
Fixing time for eye tracking
Measured: up to 3 months
Successful test numbers in each level
Measured: up to 3 months
Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start7 Jul 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit in Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Plateforme PRISME
- Responsible party
- Sponsor
- Investigators
- CHARLES Perrine, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878251
- Sponsor's protocol ID
- K180106J
- Other IDs
- 2018-A00686-49
- Acronym
- EVALDI
- Status last verified
- Jun 2022
- First submitted
- 14 Mar 2019
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
- ClinicalTrials.gov ID
- NCT03878251
- Acronym / sponsor ID
- EVALDI / K180106J
- Keywords
- Intellectual disability, Attention evaluation criteria, Games on touchscreen, Eye tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Plateforme PRISME
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 18 Mar 2019 (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.
Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.
Detailed description
The aim of the study is to develop and validate quantitative interactive attention evaluation criteria by using games on touchscreen and or eye tracking in patients with intellectual disability. Tests will have to be suitable whatever severity and etiology of intellectual disability. Tests have to evaluate attention and concentration troubles in intellectual disability.Once validated, tests could be used as outcome measures in clinical trials and as cognitive reeducation tools in intellectual disability.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| X fragile syndrome patients | Other | Device: Quantitative attention evaluation criteria in intellectual disability |
| Angelman syndrome patients | Other | Device: Quantitative attention evaluation criteria in intellectual disability |
| Rett syndrome patients | Other | Device: Quantitative attention evaluation criteria in intellectual disability |
| Patients with other genetic rare syndromes with intellectual d | Other | Device: Quantitative attention evaluation criteria in intellectual disability |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sex, with intellectual disability
- Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients
- Patients with more or less severe intellectual disability from various causes including Fragile X syndrome, Rett syndrome, Angelman syndrome and other etiologies of intellectual disabilities and intellectual disabilities without identified etiology
- Affiliation to a social security system own or affiliated (excluding AME)
- Presence of parents or legal representative
Key exclusion criteria (2 listed)
- Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
- Uncontrolled seizure disorder despite treatment
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 |
|---|---|---|
| Quantitative attention evaluation criteria in intellectual disabilityQuantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer) | Device | Angelman syndrome patients, Patients with other genetic rare syndromes with intellectual d, Rett syndrome patients, X fragile syndrome patients |
Primary outcome
Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
Time frame: up to 3 months
Test performed 1 time during a visit (1 day) can be repeated (for a maximum of 15 patients) within 3 months if an adaptation of the interactive tool is necessary
8 secondary outcomes
Maximal reached level for each test
Time frame: up to 3 months
Number of errors during the test
Time frame: up to 3 months
Time to reach each level of the test
Time frame: up to 3 months
Time to reach maximum level of the test
Time frame: up to 3 months
Total test duration
Time frame: up to 3 months
Fixing time for eye tracking
Time frame: up to 3 months
Successful test numbers in each level
Time frame: up to 3 months
Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- 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.
CHARLES Perrine, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative attention evaluation criteria in intellectual disability in people with Attention Deficit in Intellectual Disability, run by Assistance Publique - Hôpitaux de Paris 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 6 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: finished, as of the sponsor's last update on 28 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.