- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546010
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition (TDAH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France
- Recruiting
- Grenoble Alps Hospital
-
Contact:
- Annie Laurent, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Oculometric and neuropsychological tests
Oculometric tests and neuropsychological tests
|
WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between oculometric and neuropsychological tests in ADH evaluation
Time Frame: Day 1
|
Differentiation between simple oculomotor disorder and attentional-visual disorder
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annie Laurent, MD, Grenoble Alps University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC14.100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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