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

Primary Purpose

Concussion, Brain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Concussion, Brain

Eligibility Criteria

11 Years - 25 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuropsychological tests

Arm Description

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.

Outcomes

Primary Outcome Measures

Alertness time
Reaction time (ms) in the Alertness TAP test
Alertness error
Number of errors in the Alertness TAP test
Divided Attention time
Reaction time (ms) in the Divided Attention TAP test
Divided Attention error
Number of errors in the Divided Attention TAP test
Go/No-go time
Reaction time (ms) in the Go/No-go TAP test
Go/No-go error
Number of errors in the Go/No-go TAP test
Incompatibility time
Reaction time (ms) in the Incompatibility TAP test
Incompatibility error
Number of errors in the Incompatibility TAP test
Working Memory time
Reaction time (ms) in the Working Memory TAP test
Working Memory error
Number of errors in the Working Memory TAP test

Secondary Outcome Measures

Matrix reasoning
Number of errors in Matrix reasoning test
Coding
Number of errors in coding test
Symbol
Number of errors symbol search test
Digit span
Number of errors in digit span test
16-item free and cued recall
Number of recall words in 16-item free and cued recall test
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.
Stories
Number of errors in stories subtests of the Child Memory Scale (CMS)
Word pairs
Number of errors in word pairs subtests of the Child Memory Scale (CMS)
D2-R error
Number of errors in D2-R tests
D2-R time
Time (in seconds) to complete the D2-R test
Sociodemographic data
age and level of study of participants
Headaches
Presence or absence of headaches
Amnesia
Presence of anterograde or retrograde amnesia
SCAT
Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion
Sleep
Change in sleep (presence of hyper or insomnia)
Consciousness
Loss of initial consciousness or not
Position
Player position in the rugby team

Full Information

First Posted
January 17, 2023
Last Updated
July 20, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05719844
Brief Title
Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
Acronym
NeuropsyCor
Official Title
Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuropsychological tests
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuropsychological tests
Intervention Description
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)
Primary Outcome Measure Information:
Title
Alertness time
Description
Reaction time (ms) in the Alertness TAP test
Time Frame
At inclusion
Title
Alertness error
Description
Number of errors in the Alertness TAP test
Time Frame
At inclusion
Title
Divided Attention time
Description
Reaction time (ms) in the Divided Attention TAP test
Time Frame
At inclusion
Title
Divided Attention error
Description
Number of errors in the Divided Attention TAP test
Time Frame
At inclusion
Title
Go/No-go time
Description
Reaction time (ms) in the Go/No-go TAP test
Time Frame
At inclusion
Title
Go/No-go error
Description
Number of errors in the Go/No-go TAP test
Time Frame
At inclusion
Title
Incompatibility time
Description
Reaction time (ms) in the Incompatibility TAP test
Time Frame
At inclusion
Title
Incompatibility error
Description
Number of errors in the Incompatibility TAP test
Time Frame
At inclusion
Title
Working Memory time
Description
Reaction time (ms) in the Working Memory TAP test
Time Frame
At inclusion
Title
Working Memory error
Description
Number of errors in the Working Memory TAP test
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Matrix reasoning
Description
Number of errors in Matrix reasoning test
Time Frame
At inclusion
Title
Coding
Description
Number of errors in coding test
Time Frame
At inclusion
Title
Symbol
Description
Number of errors symbol search test
Time Frame
At inclusion
Title
Digit span
Description
Number of errors in digit span test
Time Frame
At inclusion
Title
16-item free and cued recall
Description
Number of recall words in 16-item free and cued recall test
Time Frame
At inclusion
Title
Complex figure
Description
Score in the complex figure of the memory efficient battery 144. Score is determined by the number of elements of the figure recalled.
Time Frame
At inclusion
Title
Stories
Description
Number of errors in stories subtests of the Child Memory Scale (CMS)
Time Frame
At inclusion
Title
Word pairs
Description
Number of errors in word pairs subtests of the Child Memory Scale (CMS)
Time Frame
At inclusion
Title
D2-R error
Description
Number of errors in D2-R tests
Time Frame
At inclusion
Title
D2-R time
Description
Time (in seconds) to complete the D2-R test
Time Frame
At inclusion
Title
Sociodemographic data
Description
age and level of study of participants
Time Frame
At inclusion
Title
Headaches
Description
Presence or absence of headaches
Time Frame
At inclusion
Title
Amnesia
Description
Presence of anterograde or retrograde amnesia
Time Frame
At inclusion
Title
SCAT
Description
Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion
Time Frame
At inclusion
Title
Sleep
Description
Change in sleep (presence of hyper or insomnia)
Time Frame
At inclusion
Title
Consciousness
Description
Loss of initial consciousness or not
Time Frame
At inclusion
Title
Position
Description
Player position in the rugby team
Time Frame
At inclusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiphaine Vidal
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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