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

NCT05719844 | Recruiting

• 1 other identifier: AOI 2021 VIDAL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (10)

• Alertness time

  Reaction time (ms) in the Alertness TAP test

  At inclusion

• Alertness error

  Number of errors in the Alertness TAP test

  At inclusion

• Divided Attention time

  Reaction time (ms) in the Divided Attention TAP test

  At inclusion

• Divided Attention error

  Number of errors in the Divided Attention TAP test

  At inclusion

• Go/No-go time

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

  At inclusion

• Go/No-go error

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

  At inclusion

• Incompatibility time

  Reaction time (ms) in the Incompatibility TAP test

  At inclusion

• Incompatibility error

  Number of errors in the Incompatibility TAP test

  At inclusion

• Working Memory time

  Reaction time (ms) in the Working Memory TAP test

  At inclusion

• Working Memory error

  Number of errors in the Working Memory TAP test

  At inclusion

Secondary Outcomes (17)

• Matrix reasoning

  At inclusion

• Coding

  At inclusion

• Symbol

  At inclusion

• Digit span

  At inclusion

• 16-item free and cued recall

  At inclusion

Study Arms (1)

Neuropsychological tests

EXPERIMENTAL

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

Interventions

Neuropsychological tests DIAGNOSTIC_TEST

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)

Neuropsychological tests

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Tiphaine Vidal

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 9, 2023
• Study Start: March 9, 2023
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): March 9, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)