Neurodevelopmental DisordersDECODENCT04844853
Neural Correlates of Tactile Prediction
A study testing electroencephalography, Tactile stimulation and Attention Network task (computerized) in people with Neurodevelopmental Disorders and Premature Birth, run by University Hospital, Caen at 1 site in France.
Trial summary
This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Premature Birth
- What is being tested?
- electroencephalography, Tactile stimulation and Attention Network task (computerized)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 30 Sep 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 24 to 35 or 72 to 83 months
- Born prematurely or term, with or without neurodevelopmental disorders (see arms)
- Parental informed consent
- Attending school
Who cannot join
- Severe IQ deficit or language impairment
- Psychotropic medication
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Comete U1075 Inserm Unicaen
Caen, 13032
Nadege Roche-Labarbe, PhD
About this study
Official title: High Resolution Electroencephalography Exploration of Tactile Prediction Development
This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.
Read the detailed description
We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. Children will be recruited from local schools and institutions. Birth will be considered premature if children were born before 36 weeks of gestational age. Children will be considered as having neurodevelopmental disorder if they receive medical and/or paramedical care at the time of measurement for neurodevelopmental disorder, including autism spectrum disorder, attention deficit with or without hyperactivity, tics, learning disorders, but all participants must be attending school at the time of measurement.
Children will come to the lab for a 2 hours session with their parents, during which they will undergo movement, attention and executive functions evaluations. Parents will fill out questionnaires evaluating their child's executive functioning and sensory profile in home/everyday settings. Children will then be equipped with 128-channels electroencephalography and proposed two tests : a modified attention network task and a tactile prediction task.
We will calculate correlations between evoked potential amplitudes during the tactile prediction trials and inhibitory conflict trials. Results will be analysed in the light of age, gestational age at birth, ecological and psychometric evaluations, and neurodevelopmental status.
- Conditions
- Neurodevelopmental Disorders, Premature Birth
- Being tested
- electroencephalography, Tactile stimulation, Attention Network task (computerized), Head-toes-knees-schoulders, Laby 5-12
- Medical subject headings
- Neurodevelopmental Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyDevice
Also called EEG
128-channel electroencephalography
Tactile stimulationDevice
Vibrotactile sequence on the forearm
Attention Network task (computerized)Behavioural
Also called Child ANT, flankers task
Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.
Head-toes-knees-schouldersBehavioural
Also called HTKS
Following motor commands such as touch your head when they are congruent or incongruent.
Laby 5-12Behavioural
Test of motor planning using labyrinths
M-ABC 2Behavioural
Test of motor functions using various subtests of gross and fine motor function.
Stroop animalsBehavioural
Stroop test for preK children using animals instead of words
| Study group | Role | What they receive |
|---|---|---|
| Preterm 2 | Experimental | 2-year-olds born prematurely Receives: Device: electroencephalography; Device: Tactile stimulation |
| Term 2 | Experimental | 2-year-olds born at term Receives: Device: electroencephalography; Device: Tactile stimulation |
| Typical 6 | Experimental | 6-year-olds with typical developement Receives: Device: electroencephalography; Device: Tactile stimulation; Behavioral: Attention Network task (computerized); Behavioral: Head-toes-knees-schoulders; Behavioral: Laby 5-12; Behavioral: M-ABC 2; Behavioral: Stroop animals |
| NDD 6 | Experimental | 6-year-olds with neurodevelopmental disorders Receives: Device: electroencephalography; Device: Tactile stimulation; Behavioral: Attention Network task (computerized); Behavioral: Head-toes-knees-schoulders; Behavioral: Laby 5-12; Behavioral: M-ABC 2; Behavioral: Stroop animals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetition suppression at 2
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Measured: 2 years
Repetition suppression at 6
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Measured: 6 years
Tactile prediction at 2
Difference of amplitude between baseline and omission segment
Measured: 2 years
Tactile prediction at 6
Difference of amplitude between baseline and omission segment
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT04844853
- Sponsor's protocol ID
- 2020-A03208-31
- Acronym
- DECODE
- Status last verified
- Jul 2022
- First submitted
- 2 Apr 2021
- Last updated
- 24 Aug 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Electroencephalography Exploration of Tactile Prediction Development
- ClinicalTrials.gov ID
- NCT04844853
- Acronym / sponsor ID
- DECODE / 2020-A03208-31
- Conditions
- Neurodevelopmental Disorders, Premature Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Apr 2021 (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 measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.
Detailed description
We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. Children will be recruited from local schools and institutions. Birth will be considered premature if children were born before 36 weeks of gestational age. Children will be considered as having neurodevelopmental disorder if they receive medical and/or paramedical care at the time of measurement for neurodevelopmental disorder, including autism spectrum disorder, attention deficit with or without hyperactivity, tics, learning disorders, but all participants must be attending school at the time of measurement.
Children will come to the lab for a 2 hours session with their parents, during which they will undergo movement, attention and executive functions evaluations. Parents will fill out questionnaires evaluating their child's executive functioning and sensory profile in home/everyday settings. Children will then be equipped with 128-channels electroencephalography and proposed two tests : a modified attention network task and a tactile prediction task.
We will calculate correlations between evoked potential amplitudes during the tactile prediction trials and inhibitory conflict trials. Results will be analysed in the light of age, gestational age at birth, ecological and psychometric evaluations, and neurodevelopmental status.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm 2 | Experimental | Device: electroencephalography, Device: Tactile stimulation2-year-olds born prematurely |
| Term 2 | Experimental | Device: electroencephalography, Device: Tactile stimulation2-year-olds born at term |
| Typical 6 | Experimental | Device: electroencephalography, Device: Tactile stimulation, Behavioral: Attention Network task (computerized), Behavioral: Head-toes-knees-schoulders, Behavioral: Laby 5-12, Behavioral: M-ABC 2, Behavioral: Stroop animals6-year-olds with typical developement |
| NDD 6 | Experimental | Device: electroencephalography, Device: Tactile stimulation, Behavioral: Attention Network task (computerized), Behavioral: Head-toes-knees-schoulders, Behavioral: Laby 5-12, Behavioral: M-ABC 2, Behavioral: Stroop animals6-year-olds with neurodevelopmental disorders |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 24 to 35 or 72 to 83 months
- Born prematurely or term, with or without neurodevelopmental disorders (see arms)
- Parental informed consent
- Attending school
Key exclusion criteria (2 listed)
- Severe IQ deficit or language impairment
- Psychotropic medication
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 |
|---|---|---|
| electroencephalographyAlso: EEG128-channel electroencephalography | Device | NDD 6, Preterm 2, Term 2, Typical 6 |
| Tactile stimulationVibrotactile sequence on the forearm | Device | NDD 6, Preterm 2, Term 2, Typical 6 |
| Attention Network task (computerized)Also: Child ANT, flankers taskComputer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers. | Behavioural | NDD 6, Typical 6 |
| Head-toes-knees-schouldersAlso: HTKSFollowing motor commands such as touch your head when they are congruent or incongruent. | Behavioural | NDD 6, Typical 6 |
| Laby 5-12Test of motor planning using labyrinths | Behavioural | NDD 6, Typical 6 |
| M-ABC 2Test of motor functions using various subtests of gross and fine motor function. | Behavioural | NDD 6, Typical 6 |
| Stroop animalsStroop test for preK children using animals instead of words | Behavioural | NDD 6, Typical 6 |
Primary outcome
Repetition suppression at 2
Time frame: 2 years
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Repetition suppression at 6
Time frame: 6 years
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Tactile prediction at 2
Time frame: 2 years
Difference of amplitude between baseline and omission segment
Tactile prediction at 6
Time frame: 6 years
Difference of amplitude between baseline and omission segment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography, Tactile stimulation and Attention Network task (computerized) in people with Neurodevelopmental Disorders and Premature Birth, 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 4 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: status not confirmed, as of the sponsor's last update on 24 Aug 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?
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?
Repetition suppression at 2 (time frame: 2 years). The study lists 4 primary outcomes in all. 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 24 Aug 2022.