NCT03942835

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

April 30, 2019

Last Update Submit

October 25, 2021

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorderattentiondistractionpsychometric testneuropsychological test validating procedurepsychostimulant

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (1)

  • Percentage of correct responses in healthy subjects and patients with ADHD.

    6 weeks

Study Arms (3)

Healthy participants aged from 6 to 90 year-old

EXPERIMENTAL
Other: experience 1 : Competitive attention test in healthy participants

patients with ADHD with no treatment

EXPERIMENTAL

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

patients with ADHD with treatment

EXPERIMENTAL

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 treatmentOther: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment

Interventions

experience 1 : Competitive attention test in healthy participantsOTHER

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).

Healthy participants aged from 6 to 90 year-old
experience 2 : Competitive attention test in patients with ADHD with no treatmentOTHER

Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.

patients with ADHD with no treatmentpatients with ADHD with treatment
experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatmentOTHER

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.

patients with ADHD with treatment

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Neurosciences de Lyon, INSERM U1028

Bron, 69675, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 8, 2019

Study Start

January 21, 2020

Primary Completion

March 20, 2021

Study Completion

April 20, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

FR(1)