- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05719844
Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players (NeuropsyCor)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective is to carry out a complete neuropsychological assessment, detailing the attentional and executive aspects using the TAP computerized battery. In addition, various paper-and-pencil tests, standardized in French, more commonly used in the context of neuropsychological data related to concussions in athletes, will also be administered. These assess processing speed, short-term memory and auditory-verbal working memory capacity, episodic memory and selective attention. This preliminary study would make it possible to shed light on the links that may exist between performance in the various tests proposed and the characteristics inherent in the symptomatology of concussion. Furthermore, it seems relevant to compare the results of computerized tests with other paper-and-pencil tests but also with the performance of individuals who have no history of concussion with the practice of a non-contact sport.
The results of this study would make it possible in practice to have a neuropsychological assessment more specific to cerebral concussion, with a potentially reduced consultation time due to the use of more sensitive tools, and therefore, an earlier rehabilitative intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise LACLAUTRE
- Phone Number: +334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
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-
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Clermont-Ferrand, France, 63000
- Recruiting
- CHU de Clermont-Ferrand
-
Contact:
- LISE LACLAUTRE
- Phone Number: +33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients :
- concussion in the context of the practice of rugby
- French or reading French without help
- Controls :
- no concussion
- practicing a non-contact sport (athletics, rowing, badminton, capoeira, circus, running, crossfit, cycling, dancing, climbing, fencing, fitness, golf, gymnastics, bodybuilding, swimming, skating, Qi Gong, Taï chi, tennis, table tennis, shooting, trail running, volleyball, water polo) within a sports association
- age matched to patient (+/- 1 year)
- study level matched to patient (+/- 1 year)
- French or reading French without help
Exclusion Criteria:
- Patients :
- Legal protection measure
- Other neurological or psychiatric pathologies prior to concussion episodes
- Diagnosis of a neurodevelopmental disorder in childhood
- Score less than or equal to 5/19 on the "Matrix" subtest (intellectual retardation)
- Addictive behaviors
- Current major depressive disorder or treated with antidepressants or benzodiazepines for less than 3 months
- Severe visual or motor problems that may interfere with the performance of the tests
- Controls :
- Legal protection measure
- History of proven concussion
- Other neurological or psychiatric pathologies
- Diagnosis of a neurodevelopmental disorder in childhood
- Score less than or equal to 5/19 on the "Matrix" subtest (intellectual retardation)
- Addictive behaviors
- Current major depressive episode or treated with antidepressants or benzodiazepines for less than 3 months
- Severe visual or motor problems that may interfere with the performance of the tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neuropsychological tests
The neuropsychological tests are computerized (TAP battery) or paper-and-pencil tests.
They assess processing speed, short-term memory and auditory-verbal working memory capacity, episodic memory and selective attention.
|
List of neuropsychological tests:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alertness time
Time Frame: At inclusion
|
Reaction time (ms) in the Alertness TAP test
|
At inclusion
|
|
Alertness error
Time Frame: At inclusion
|
Number of errors in the Alertness TAP test
|
At inclusion
|
|
Divided Attention time
Time Frame: At inclusion
|
Reaction time (ms) in the Divided Attention TAP test
|
At inclusion
|
|
Divided Attention error
Time Frame: At inclusion
|
Number of errors in the Divided Attention TAP test
|
At inclusion
|
|
Go/No-go time
Time Frame: At inclusion
|
Reaction time (ms) in the Go/No-go TAP test
|
At inclusion
|
|
Go/No-go error
Time Frame: At inclusion
|
Number of errors in the Go/No-go TAP test
|
At inclusion
|
|
Incompatibility time
Time Frame: At inclusion
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Reaction time (ms) in the Incompatibility TAP test
|
At inclusion
|
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Incompatibility error
Time Frame: At inclusion
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Number of errors in the Incompatibility TAP test
|
At inclusion
|
|
Working Memory time
Time Frame: At inclusion
|
Reaction time (ms) in the Working Memory TAP test
|
At inclusion
|
|
Working Memory error
Time Frame: At inclusion
|
Number of errors in the Working Memory TAP test
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Matrix reasoning
Time Frame: At inclusion
|
Number of errors in Matrix reasoning test
|
At inclusion
|
|
Coding
Time Frame: At inclusion
|
Number of errors in coding test
|
At inclusion
|
|
Symbol
Time Frame: At inclusion
|
Number of errors symbol search test
|
At inclusion
|
|
Digit span
Time Frame: At inclusion
|
Number of errors in digit span test
|
At inclusion
|
|
16-item free and cued recall
Time Frame: At inclusion
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Number of recall words in 16-item free and cued recall test
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At inclusion
|
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Complex figure
Time Frame: At inclusion
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Score in the complex figure of the memory efficient battery 144.
Score is determined by the number of elements of the figure recalled.
|
At inclusion
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Stories
Time Frame: At inclusion
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Number of errors in stories subtests of the Child Memory Scale (CMS)
|
At inclusion
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Word pairs
Time Frame: At inclusion
|
Number of errors in word pairs subtests of the Child Memory Scale (CMS)
|
At inclusion
|
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D2-R error
Time Frame: At inclusion
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Number of errors in D2-R tests
|
At inclusion
|
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D2-R time
Time Frame: At inclusion
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Time (in seconds) to complete the D2-R test
|
At inclusion
|
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Sociodemographic data
Time Frame: At inclusion
|
age and level of study of participants
|
At inclusion
|
|
Headaches
Time Frame: At inclusion
|
Presence or absence of headaches
|
At inclusion
|
|
Amnesia
Time Frame: At inclusion
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Presence of anterograde or retrograde amnesia
|
At inclusion
|
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SCAT
Time Frame: At inclusion
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Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion
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At inclusion
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Sleep
Time Frame: At inclusion
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Change in sleep (presence of hyper or insomnia)
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At inclusion
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Consciousness
Time Frame: At inclusion
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Loss of initial consciousness or not
|
At inclusion
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Position
Time Frame: At inclusion
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Player position in the rugby team
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At inclusion
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Collaborators and Investigators
Investigators
- Principal Investigator: Tiphaine Vidal, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOI 2021 VIDAL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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