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Psychometric Validation of the Competitive Attention Test (CAT)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
experience 1 : Competitive attention test in healthy participants
experience 2 : Competitive attention test in patients with ADHD with no treatment
experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, attention, distraction, psychometric test, neuropsychological test validating procedure, psychostimulant

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Recherche en Neurosciences de Lyon, INSERM U1028

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy participants aged from 6 to 90 year-old

patients with ADHD with no treatment

patients with ADHD with treatment

Arm Description

patients with ADHD aged from 6 to 90 year-old with no treatment

patients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate)

Outcomes

Primary Outcome Measures

Reaction times in healthy subjects and patients with ADHD.
Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.

Secondary Outcome Measures

Percentage of correct responses in healthy subjects and patients with ADHD.
Percentage of correct responses obtained with the CAT test in healthy participants and in patients with ADHD.

Full Information

First Posted
April 30, 2019
Last Updated
October 25, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03942835
Brief Title
Psychometric Validation of the Competitive Attention Test
Acronym
CAT
Official Title
Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
abandonment
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, attention, distraction, psychometric test, neuropsychological test validating procedure, psychostimulant

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy participants aged from 6 to 90 year-old
Arm Type
Experimental
Arm Title
patients with ADHD with no treatment
Arm Type
Experimental
Arm Description
patients with ADHD aged from 6 to 90 year-old with no treatment
Arm Title
patients with ADHD with treatment
Arm Type
Experimental
Arm Description
patients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate)
Intervention Type
Other
Intervention Name(s)
experience 1 : Competitive attention test in healthy participants
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
experience 2 : Competitive attention test in patients with ADHD with no treatment
Intervention Description
Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.
Intervention Type
Other
Intervention Name(s)
experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reaction times in healthy subjects and patients with ADHD.
Description
Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of correct responses in healthy subjects and patients with ADHD.
Description
Percentage of correct responses obtained with the CAT test in healthy participants and in patients with ADHD.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centre de Recherche en Neurosciences de Lyon, INSERM U1028
City
Bron
ZIP/Postal Code
69675
Country
France

12. IPD Sharing Statement

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Psychometric Validation of the Competitive Attention Test

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