Neural Correlates of Tactile Prediction (DECODE)
Primary Purpose
Neurodevelopmental Disorders, Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalography
Tactile stimulation
Attention Network task (computerized)
Head-toes-knees-schoulders
Laby 5-12
M-ABC 2
Stroop animals
Sponsored by
About this trial
This is an interventional basic science trial for Neurodevelopmental Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe IQ deficit or language impairment
- Psychotropic medication
Sites / Locations
- Comete U1075 Inserm UnicaenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Preterm 2
Term 2
Typical 6
NDD 6
Arm Description
2-year-olds born prematurely
2-year-olds born at term
6-year-olds with typical developement
6-year-olds with neurodevelopmental disorders
Outcomes
Primary Outcome Measures
Repetition suppression at 2
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Repetition suppression at 6
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Tactile prediction at 2
Difference of amplitude between baseline and omission segment
Tactile prediction at 6
Difference of amplitude between baseline and omission segment
Secondary Outcome Measures
Full Information
NCT ID
NCT04844853
First Posted
April 2, 2021
Last Updated
August 23, 2022
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT04844853
Brief Title
Neural Correlates of Tactile Prediction
Acronym
DECODE
Official Title
High Resolution Electroencephalography Exploration of Tactile Prediction Development
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders, Premature Birth
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preterm 2
Arm Type
Experimental
Arm Description
2-year-olds born prematurely
Arm Title
Term 2
Arm Type
Experimental
Arm Description
2-year-olds born at term
Arm Title
Typical 6
Arm Type
Experimental
Arm Description
6-year-olds with typical developement
Arm Title
NDD 6
Arm Type
Experimental
Arm Description
6-year-olds with neurodevelopmental disorders
Intervention Type
Device
Intervention Name(s)
electroencephalography
Other Intervention Name(s)
EEG
Intervention Description
128-channel electroencephalography
Intervention Type
Device
Intervention Name(s)
Tactile stimulation
Intervention Description
Vibrotactile sequence on the forearm
Intervention Type
Behavioral
Intervention Name(s)
Attention Network task (computerized)
Other Intervention Name(s)
Child ANT, flankers task
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Head-toes-knees-schoulders
Other Intervention Name(s)
HTKS
Intervention Description
Following motor commands such as touch your head when they are congruent or incongruent.
Intervention Type
Behavioral
Intervention Name(s)
Laby 5-12
Intervention Description
Test of motor planning using labyrinths
Intervention Type
Behavioral
Intervention Name(s)
M-ABC 2
Intervention Description
Test of motor functions using various subtests of gross and fine motor function.
Intervention Type
Behavioral
Intervention Name(s)
Stroop animals
Intervention Description
Stroop test for preK children using animals instead of words
Primary Outcome Measure Information:
Title
Repetition suppression at 2
Description
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Time Frame
2 years
Title
Repetition suppression at 6
Description
Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Time Frame
6 years
Title
Tactile prediction at 2
Description
Difference of amplitude between baseline and omission segment
Time Frame
2 years
Title
Tactile prediction at 6
Description
Difference of amplitude between baseline and omission segment
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Severe IQ deficit or language impairment
Psychotropic medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadege Roche-Labarbe, PhD
Phone
+33(0)649922568
Email
nadege.roche@unicaen.fr
Facility Information:
Facility Name
Comete U1075 Inserm Unicaen
City
Caen
ZIP/Postal Code
13032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadege Roche-Labarbe, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Neural Correlates of Tactile Prediction
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