Clinical trial NCT05719844: Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
Official title: Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 90
Sex: MALE
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to test the ability of a computerized neuropsychological battery to identify attentional disorders resulting from a concussion occurring during the practice of rugby. Thirty young people with a concussion (11-25 years old) will take several neuropsychological tests. Researchers will compare their results with those of young athletes without concussion to see the effect of concussion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alertness time
timeFrame: At inclusion
measure: Alertness error
timeFrame: At inclusion
measure: Divided Attention time
timeFrame: At inclusion
measure: Divided Attention error
timeFrame: At inclusion
measure: Go/No-go time
timeFrame: At inclusion
measure: Go/No-go error
timeFrame: At inclusion
measure: Incompatibility time
timeFrame: At inclusion
measure: Incompatibility error
timeFrame: At inclusion
measure: Working Memory time
timeFrame: At inclusion
measure: Working Memory error
timeFrame: At inclusion
Secondary outcomes:
measure: Matrix reasoning
timeFrame: At inclusion
measure: Coding
timeFrame: At inclusion
measure: Symbol
timeFrame: At inclusion
measure: Digit span
timeFrame: At inclusion
measure: 16-item free and cued recall
timeFrame: At inclusion
measure: Complex figure
timeFrame: At inclusion
measure: Stories
timeFrame: At inclusion
measure: Word pairs
timeFrame: At inclusion
measure: D2-R error
timeFrame: At inclusion
measure: D2-R time
timeFrame: At inclusion
measure: Sociodemographic data
timeFrame: At inclusion
measure: Headaches
timeFrame: At inclusion
measure: Amnesia
timeFrame: At inclusion
measure: SCAT
timeFrame: At inclusion
measure: Sleep
timeFrame: At inclusion
measure: Consciousness
timeFrame: At inclusion
measure: Position
timeFrame: At inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Tiphaine Vidal
role: PRINCIPAL_INVESTIGATOR
References: