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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05719844
Collaborator
(none)
90
1
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neuropsychological tests
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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.

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 pairs of the Children Memory Scale for children only (< 17 years old)

Outcome Measures

Primary Outcome Measures

  1. Alertness time [At inclusion]

    Reaction time (ms) in the Alertness TAP test

  2. Alertness error [At inclusion]

    Number of errors in the Alertness TAP test

  3. Divided Attention time [At inclusion]

    Reaction time (ms) in the Divided Attention TAP test

  4. Divided Attention error [At inclusion]

    Number of errors in the Divided Attention TAP test

  5. Go/No-go time [At inclusion]

    Reaction time (ms) in the Go/No-go TAP test

  6. Go/No-go error [At inclusion]

    Number of errors in the Go/No-go TAP test

  7. Incompatibility time [At inclusion]

    Reaction time (ms) in the Incompatibility TAP test

  8. Incompatibility error [At inclusion]

    Number of errors in the Incompatibility TAP test

  9. Working Memory time [At inclusion]

    Reaction time (ms) in the Working Memory TAP test

  10. Working Memory error [At inclusion]

    Number of errors in the Working Memory TAP test

Secondary Outcome Measures

  1. Matrix reasoning [At inclusion]

    Number of errors in Matrix reasoning test

  2. Coding [At inclusion]

    Number of errors in coding test

  3. Symbol [At inclusion]

    Number of errors symbol search test

  4. Digit span [At inclusion]

    Number of errors in digit span test

  5. 16-item free and cued recall [At inclusion]

    Number of recall words in 16-item free and cued recall test

  6. Complex figure [At inclusion]

    Score in the complex figure of the memory efficient battery 144. Score is determined by the number of elements of the figure recalled.

  7. Stories [At inclusion]

    Number of errors in stories subtests of the Child Memory Scale (CMS)

  8. Word pairs [At inclusion]

    Number of errors in word pairs subtests of the Child Memory Scale (CMS)

  9. D2-R error [At inclusion]

    Number of errors in D2-R tests

  10. D2-R time [At inclusion]

    Time (in seconds) to complete the D2-R test

  11. Sociodemographic data [At inclusion]

    age and level of study of participants

  12. Headaches [At inclusion]

    Presence or absence of headaches

  13. Amnesia [At inclusion]

    Presence of anterograde or retrograde amnesia

  14. SCAT [At inclusion]

    Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion

  15. Sleep [At inclusion]

    Change in sleep (presence of hyper or insomnia)

  16. Consciousness [At inclusion]

    Loss of initial consciousness or not

  17. Position [At inclusion]

    Player position in the rugby team

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 25 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Tiphaine Vidal, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT05719844
Other Study ID Numbers:
  • AOI 2021 VIDAL
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 9, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2023