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出境医 / 临床实验 / Psychometric Validation of the Competitive Attention Test (CAT)
Psychometric Validation of the Competitive Attention Test (CAT)
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 | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | 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 | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| 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 21, 2020 |
| Estimated Primary Completion Date : | January 21, 2024 |
| Estimated Study Completion Date : | January 21, 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).
|
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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.
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Outcome Measures
Primary Outcome Measures :
- 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 :
- 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 Years 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 | Recruiting |
| Bron, France, 69675 | |
| 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 | |
| Principal Investigator: Aurélie BIDET-CAULET, PhD, CR | |
Sponsors and Collaborators
Hospices Civils de Lyon
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 30, 2019 | ||||||||
| First Posted Date ICMJE | May 8, 2019 | ||||||||
| Last Update Posted Date | January 27, 2020 | ||||||||
| Actual Study Start Date ICMJE | January 21, 2020 | ||||||||
| Estimated Primary Completion Date | January 21, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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.
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Psychometric Validation of the Competitive Attention Test | ||||||||
| Official Title ICMJE | Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention | ||||||||
| 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:
|
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
180 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | January 21, 2024 | ||||||||
| Estimated Primary Completion Date | January 21, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: healthy major participants:
healthy minor participants:
ADHD minor patients:
Exclusion Criteria: healthy major participants
healthy minor participants:
ADHD minor patients:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Years to 90 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03942835 | ||||||||
| Other Study ID Numbers ICMJE | 69HCL18_0376 2018-A02597-48 ( Other Identifier: ID-RCB ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | January 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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