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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Psychometric Validation of the Competitive Attention Test

Clinicaltrials.gov identifier NCT03942835

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted January 27, 2020

Study Description

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:Attention Deficit Hyperactivity Disorder
  • Intervention/Treatment: 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
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: January 2024
  • Estimated Study Completion Date: January 2024
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 6 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
Contacts

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

France
Centre de Recherche en Neurosciences de Lyon, INSERM U1028
Bron

Sponsors and Collaborators

Hospices Civils de Lyon

More Information
  • Responsible Party: Hospices Civils de Lyon
  • ClinicalTrials.gov Identifier: NCT03942835 History of Changes
  • Other Study ID Numbers: 69HCL18_0376, 2018-A02597-48
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: January 27, 2020
  • Last Verified: January 2020
  • 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
    distraction
    psychometric test
    neuropsychological test validating procedure
    psychostimulant
    Attention Deficit Hyperactivity Disorder
  • Additional relevant MeSH terms: Hyperkinesis Attention Deficit Disorder with Hyperactivity