Attention Deficit DisorderMEDiATENCT04548245
Markers of Executive Attention Development in Preschoolers
An observational study of Attention Deficit Disorder, run by University Hospital, Caen at 1 site in France.
Trial summary
This project aims to identify precursors of executive attention that can serve as early markers of ADD. Read more about this study
- Who is it for?
- Ages 48 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- EEG
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Oct 2023
- Phase
- Observational
- 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 48 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preschool children born preterm vs term
Who may be able to join
- Normal schooling
- Parental consent
Who cannot join
- Psychotropic drug
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Comete U1075 Inserm Unicaen
Caen, 14032
Nadege Roche-Labarbe, PhD
About this study
This project aims to identify precursors of executive attention that can serve as early markers of ADD.
- Conditions
- Attention Deficit Disorder
- Being tested
- EEG
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
EEG
| Study group | Role | What they receive |
|---|---|---|
| Term | Not described Receives: Device: EEG | |
| Preterm | Not described Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence
Measured: at 4 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Feb 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548245
- Sponsor's protocol ID
- 2020-A01503-36
- Acronym
- MEDiATE
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2020
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Executive Attention Development in Preschoolers
- ClinicalTrials.gov ID
- NCT04548245
- Acronym / sponsor ID
- MEDiATE / 2020-A01503-36
- Conditions
- Attention Deficit Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 14 Sep 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.
This project aims to identify precursors of executive attention that can serve as early markers of ADD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term | – | Device: EEG |
| Preterm | – | Device: EEG |
Who may qualify
- Ages
- 48 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preschool children born preterm vs term
Key inclusion criteria (2 listed)
- Normal schooling
- Parental consent
Key exclusion criteria (1 listed)
- Psychotropic drug
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 |
|---|---|---|
| EEGEEG | Device | Preterm, Term |
Primary outcome
Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence
Time frame: at 4 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder, run by University Hospital, Caen 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadege Roche-Labarbe, PhD (+33(0)649922568, nadege.roche@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence (time frame: at 4 years old). 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 13 Feb 2023.