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Recruiting NCT05719844

Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players

No phase Interventional Concussion, Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuropsychological tests.
Who it may be relevant to
Registry conditions: Concussion, Brain. Basic parameters: 11 years — 25 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Neuropsychological tests
    List of neuropsychological tests: * Matrix reasoning * D2-R * Coding * Symbol search * Digit span * Alertness (computerized TAP battery) * Divided Attention (computerized TAP battery) * Go / No go (computerized TAP battery) * Incompatibility (computerized TAP battery) * Working memory (computerized TAP battery) * 16-item Free and Cued Recall or Stories subtest of the Children Memory Scale (CMS) for children only (\< 17 years old) * complex figure of the memory efficiency battery 144 or Word pai

Primary outcome measures

  • Alertness time [Time frame: At inclusion]
  • Alertness error [Time frame: At inclusion]
  • Divided Attention time [Time frame: At inclusion]
  • Divided Attention error [Time frame: At inclusion]
  • Go/No-go time [Time frame: At inclusion]
  • Go/No-go error [Time frame: At inclusion]
  • Incompatibility time [Time frame: At inclusion]
  • Incompatibility error [Time frame: At inclusion]
  • Working Memory time [Time frame: At inclusion]
  • Working Memory error [Time frame: At inclusion]
Secondary outcome measures (12)
  • Matrix reasoning [Time frame: At inclusion]
  • Coding [Time frame: At inclusion]
  • Symbol [Time frame: At inclusion]
  • Digit span [Time frame: At inclusion]
  • 16-item free and cued recall [Time frame: At inclusion]
  • Complex figure [Time frame: At inclusion]
  • Stories [Time frame: At inclusion]
  • Word pairs [Time frame: At inclusion]
  • D2-R error [Time frame: At inclusion]
  • D2-R time [Time frame: At inclusion]
  • Sociodemographic data [Time frame: At inclusion]
  • Headaches [Time frame: At inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT05719844 · AOI 2021 VIDAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗