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Psychometric Validation of the Competitive Attention Test (CAT)

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ClinicalTrials.gov Identifier: NCT03942835
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

  • a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
  • testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
  • testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: experience 1 : Competitive attention test in healthy participants Other: experience 2 : Competitive attention test in patients with ADHD with no treatment Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : January 21, 2024
Estimated Study Completion Date : January 21, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy participants aged from 6 to 90 year-old Other: experience 1 : Competitive attention test in healthy participants
Comparison of behavioral measures (reaction times and percentage of correct responses) obtained twice with the CAT test in healthy participants (2 to 6 weeks apart).
Experimental: patients with ADHD with no treatment
patients with ADHD aged from 6 to 90 year-old with no treatment
 Other: experience 2 : Competitive attention test in patients with ADHD with no treatment
Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.
Experimental: patients with ADHD with treatment
patients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate)
 Other: experience 2 : Competitive attention test in patients with ADHD with no treatment
Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.

Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment
Behavioral (reaction times and percentage of correct responses) and EEG measures obtained with the CAT test in patients with ADHD before and after psychostimulant treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Reaction times in healthy subjects and patients with ADHD. [ Time Frame: 6 weeks ]
    Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.


Secondary Outcome Measures :
  1. Percentage of correct responses in healthy subjects and patients with ADHD. [ Time Frame: 6 weeks ]
    Percentage of correct responses obtained with the CAT test in healthy participants and in patients with ADHD.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

healthy major participants:

  • Age from 18 to 90 year-old
  • Informed consent to participate in the study
  • No neurological or psychiatric disorder
  • No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder

healthy minor participants:

  • Age from 6 to 17 year-old
  • Informed consent of parents or guardians for the child's participation in the study
  • No neurological or psychiatric disorder
  • No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, Attention deficit disorder

ADHD minor patients:

  • Age from 6 to 17 year-old
  • Informed consent of parents or guardians for the child's participation in the study
  • ADHD Diagnosis with or without hyperactivity
  • No psychiatric history other than ADHD.
  • For Experience 3: treatment in progress.

Exclusion Criteria:

healthy major participants

  • Age below 18 or above 90 year-old
  • unaffiliated or non-beneficiaries of the social security scheme

healthy minor participants:

  • Age below 6 or above 18 year-old
  • unaffiliated or non-beneficiaries of the social security scheme

ADHD minor patients:

  • Age below 6 or above 18 year-old
  • unaffiliated or non-beneficiaries of the social security scheme
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942835


Contacts
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Contact: Aurélie BIDET-CAULET, PhD, CR 04 72 13 89 31 ext +33 aurelie.bidet-caulet@inserm.fr
Contact: Lesly FORNONI, TR 04 72 13 89 22 ext +33 lesly.fornoni@inserm.fr

Locations
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France
Centre de Recherche en Neurosciences de Lyon, INSERM U1028 Recruiting
Bron, France, 69675
Contact: Aurélie BIDET-CAULET, PhD, CR    04 72 13 89 31 ext +33    aurelie.bidet-caulet@inserm.fr   
Contact: Lesly FORNONI, TR    04 72 13 89 22 ext +33    lesly.fornoni@inserm.fr   
Principal Investigator: Aurélie BIDET-CAULET, PhD, CR         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03942835    
Other Study ID Numbers: 69HCL18_0376
2018-A02597-48 ( Other Identifier: ID-RCB )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Attention Deficit Hyperactivity Disorder
attention
distraction
 psychometric test
neuropsychological test validating procedure
psychostimulant
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases