- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942835
Psychometric Validation of the Competitive Attention Test (CAT)
October 25, 2021 updated by: Hospices Civils de Lyon
Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69675
- Centre de Recherche en Neurosciences de Lyon, INSERM U1028
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy participants aged from 6 to 90 year-old
|
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
|
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2020
Primary Completion (Actual)
March 20, 2021
Study Completion (Actual)
April 20, 2021
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0376
- 2018-A02597-48 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.