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Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition (TDAH)

Primary Purpose

Attention Deficit-Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
Oculometric tests
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention Deficit-Hyperactivity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between 8 and 12 years old
  • Boys and girls
  • DSM-IV-TR diagnostic criteria for ADH
  • Children with methylprednisone treatment
  • Social security affiliation
  • signed informed consent

Exclusion Criteria:

  • specialised scholarship
  • refusal from children or parents
  • too law results in WISC test (pre-inclusion test)

Sites / Locations

  • Grenoble Alps HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oculometric and neuropsychological tests

Arm Description

Oculometric tests and neuropsychological tests

Outcomes

Primary Outcome Measures

Correlation between oculometric and neuropsychological tests in ADH evaluation
Differentiation between simple oculomotor disorder and attentional-visual disorder

Secondary Outcome Measures

Full Information

First Posted
May 18, 2018
Last Updated
June 4, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03546010
Brief Title
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
Acronym
TDAH
Official Title
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2014 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

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
The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care. We should then be able to compare eye tracking with neuropsychological parameters. The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit-Hyperactivity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oculometric and neuropsychological tests
Arm Type
Experimental
Arm Description
Oculometric tests and neuropsychological tests
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological tests
Intervention Description
WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test
Intervention Type
Behavioral
Intervention Name(s)
Oculometric tests
Intervention Description
When the subject see a peripheric target, he should take a look not at the target but in the controlateral half-field, at a mirror position. This is called an anti-saccade task.
Primary Outcome Measure Information:
Title
Correlation between oculometric and neuropsychological tests in ADH evaluation
Description
Differentiation between simple oculomotor disorder and attentional-visual disorder
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 8 and 12 years old Boys and girls DSM-IV-TR diagnostic criteria for ADH Children with methylprednisone treatment Social security affiliation signed informed consent Exclusion Criteria: specialised scholarship refusal from children or parents too law results in WISC test (pre-inclusion test)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Laurent, MD
Phone
04 76 76 54 19
Email
AnnieLaurent@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Guyader, MCD UJF
Phone
04 76 57 43 72
Email
nathalie.guyader@gipsa-lab.grenoble-inp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annie Laurent, MD
Organizational Affiliation
Grenoble Alps University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble Alps Hospital
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Laurent, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23293609
Citation
Malsert J, Guyader N, Chauvin A, Polosan M, Szekely D, Bougerol T, Marendaz C. Saccadic performance and cortical excitability as trait-markers and state-markers in rapid cycling bipolar disorder: a two-case follow-up study. Front Psychiatry. 2013 Jan 4;3:112. doi: 10.3389/fpsyt.2012.00112. eCollection 2012.
Results Reference
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Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition

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