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MEDiATE: Markers of Executive Attention Development in Preschoolers

Sponsor
University Hospital, Caen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04548245
Collaborator
(none)
70
Enrollment
1
Location
19.9
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project aims to identify precursors of executive attention that can serve as early markers of ADD.

Condition or Disease Intervention/Treatment Phase
  • Device: EEG

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Markers of Executive Attention Development in Preschoolers
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Term

Device: EEG
EEG
Preterm

Device: EEG
EEG

Outcome Measures

Primary Outcome Measures

  1. Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence [at 4 years old]

Eligibility Criteria

Criteria

Ages Eligible for Study:
48 Months to 60 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Normal schooling

  • Parental consent

Exclusion Criteria:
  • Psychotropic drug

Contacts and Locations

Locations

Site City State Country Postal Code
1 Comete U1075 Inserm Unicaen Caen France 14032

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT04548245
Other Study ID Numbers:
  • 2020-A01503-36
First Posted:
Sep 14, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 9, 2022