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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Unknown status
CT.gov ID
NCT03546010
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
55.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Neuropsychological tests
  • Behavioral: Oculometric tests
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
Actual Study Start Date :
May 5, 2014
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oculometric and neuropsychological tests

Oculometric tests and neuropsychological tests

Behavioral: Neuropsychological tests
WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test

Behavioral: Oculometric tests
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.

Outcome Measures

Primary Outcome Measures

  1. Correlation between oculometric and neuropsychological tests in ADH evaluation [Day 1]

    Differentiation between simple oculomotor disorder and attentional-visual disorder

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grenoble Alps Hospital Grenoble France

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Annie Laurent, MD, Grenoble Alps University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT03546010
Other Study ID Numbers:
  • 38RC14.100
First Posted:
Jun 6, 2018
Last Update Posted:
Jun 6, 2018
Last Verified:
Jun 1, 2018
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:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Jun 6, 2018