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

Concussion, Brain Clinical Trial

— NeuropsyCor  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719844
• Other study ID #: AOI 2021 VIDAL
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 11 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alertness time	Reaction time (ms) in the Alertness TAP test	At inclusion
Primary	Alertness error	Number of errors in the Alertness TAP test	At inclusion
Primary	Divided Attention time	Reaction time (ms) in the Divided Attention TAP test	At inclusion
Primary	Divided Attention error	Number of errors in the Divided Attention TAP test	At inclusion
Primary	Go/No-go time	Reaction time (ms) in the Go/No-go TAP test	At inclusion
Primary	Go/No-go error	Number of errors in the Go/No-go TAP test	At inclusion
Primary	Incompatibility time	Reaction time (ms) in the Incompatibility TAP test	At inclusion
Primary	Incompatibility error	Number of errors in the Incompatibility TAP test	At inclusion
Primary	Working Memory time	Reaction time (ms) in the Working Memory TAP test	At inclusion
Primary	Working Memory error	Number of errors in the Working Memory TAP test	At inclusion
Secondary	Matrix reasoning	Number of errors in Matrix reasoning test	At inclusion
Secondary	Coding	Number of errors in coding test	At inclusion
Secondary	Symbol	Number of errors symbol search test	At inclusion
Secondary	Digit span	Number of errors in digit span test	At inclusion
Secondary	16-item free and cued recall	Number of recall words in 16-item free and cued recall test	At inclusion
Secondary	Complex figure	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
Secondary	Stories	Number of errors in stories subtests of the Child Memory Scale (CMS)	At inclusion
Secondary	Word pairs	Number of errors in word pairs subtests of the Child Memory Scale (CMS)	At inclusion
Secondary	D2-R error	Number of errors in D2-R tests	At inclusion
Secondary	D2-R time	Time (in seconds) to complete the D2-R test	At inclusion
Secondary	Sociodemographic data	age and level of study of participants	At inclusion
Secondary	Headaches	Presence or absence of headaches	At inclusion
Secondary	Amnesia	Presence of anterograde or retrograde amnesia	At inclusion
Secondary	SCAT	Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion	At inclusion
Secondary	Sleep	Change in sleep (presence of hyper or insomnia)	At inclusion
Secondary	Consciousness	Loss of initial consciousness or not	At inclusion
Secondary	Position	Player position in the rugby team	At inclusion