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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03942835
Other study ID # 69HCL18_0376
Secondary ID 2018-A02597-48
Status Terminated
Phase N/A
First received
Last updated
Start date January 21, 2020
Est. completion date April 20, 2021

Study information

Verified date October 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date April 20, 2021
Est. primary completion date March 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

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).
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.
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.

Locations

Country Name City State
France Centre de Recherche en Neurosciences de Lyon, INSERM U1028 Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 6 weeks
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