Concussion, BrainNeuropsyCorNCT05719844
Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
A study testing Neuropsychological tests in people with Concussion, Brain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 11 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 9 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- age matched to patient (+/- 1 year)
- study level matched to patient (+/- 1 year)
- French or reading French without help
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
About this study
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.
Read the 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.
- Conditions
- Concussion, Brain
- Being tested
- Neuropsychological tests
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alertness time
Reaction time (ms) in the Alertness TAP test
Measured: At inclusion
Alertness error
Number of errors in the Alertness TAP test
Measured: At inclusion
Divided Attention time
Reaction time (ms) in the Divided Attention TAP test
Measured: At inclusion
Divided Attention error
Number of errors in the Divided Attention TAP test
Measured: At inclusion
Go/No-go time
Reaction time (ms) in the Go/No-go TAP test
Measured: At inclusion
Go/No-go error
Number of errors in the Go/No-go TAP test
Measured: At inclusion
Incompatibility time
Reaction time (ms) in the Incompatibility TAP test
Measured: At inclusion
Incompatibility error
Number of errors in the Incompatibility TAP test
Measured: At inclusion
Working Memory time
Reaction time (ms) in the Working Memory TAP test
Measured: At inclusion
Working Memory error
Number of errors in the Working Memory TAP test
Measured: At inclusion
Secondary outcomes (17)
Matrix reasoning
Number of errors in Matrix reasoning test
Measured: At inclusion
Coding
Number of errors in coding test
Measured: At inclusion
Symbol
Number of errors symbol search test
Measured: At inclusion
Digit span
Number of errors in digit span test
Measured: At inclusion
16-item free and cued recall
Number of recall words in 16-item free and cued recall test
Measured: At inclusion
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.
Measured: At inclusion
Stories
Number of errors in stories subtests of the Child Memory Scale (CMS)
Measured: At inclusion
Word pairs
Number of errors in word pairs subtests of the Child Memory Scale (CMS)
Measured: At inclusion
D2-R error
Number of errors in D2-R tests
Measured: At inclusion
D2-R time
Time (in seconds) to complete the D2-R test
Measured: At inclusion
Sociodemographic data
age and level of study of participants
Measured: At inclusion
Headaches
Presence or absence of headaches
Measured: At inclusion
Amnesia
Presence of anterograde or retrograde amnesia
Measured: At inclusion
SCAT
Symptom severity score on the Sport Concussion Assessment Tool (SCAT), range 0-132 (minimum-maximum), a higher score representing a more severe concussion
Measured: At inclusion
Sleep
Change in sleep (presence of hyper or insomnia)
Measured: At inclusion
Consciousness
Loss of initial consciousness or not
Measured: At inclusion
Position
Player position in the rugby team
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start9 Mar 2023
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine Vidal, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719844
- Sponsor's protocol ID
- AOI 2021 VIDAL
- Acronym
- NeuropsyCor
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players
- ClinicalTrials.gov ID
- NCT05719844
- Acronym / sponsor ID
- NeuropsyCor / AOI 2021 VIDAL
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological tests | Experimental | Diagnostic Test: Neuropsychological testsThe 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. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients :
- concussion in the context of the practice of rugby
- French or reading French without help
- Controls :
- no concussion
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsList 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) | Diagnostic test | Neuropsychological tests |
Primary outcome
Alertness time
Time frame: At inclusion
Reaction time (ms) in the Alertness TAP test
Alertness error
Time frame: At inclusion
Number of errors in the Alertness TAP test
Divided Attention time
Time frame: At inclusion
Reaction time (ms) in the Divided Attention TAP test
Divided Attention error
Time frame: At inclusion
Number of errors in the Divided Attention TAP test
Go/No-go time
Time frame: At inclusion
Reaction time (ms) in the Go/No-go TAP test
Go/No-go error
Time frame: At inclusion
Number of errors in the Go/No-go TAP test
Incompatibility time
Time frame: At inclusion
Reaction time (ms) in the Incompatibility TAP test
Incompatibility error
Time frame: At inclusion
Number of errors in the Incompatibility TAP test
Working Memory time
Time frame: At inclusion
Reaction time (ms) in the Working Memory TAP test
Working Memory error
Time frame: At inclusion
Number of errors in the Working Memory TAP test
17 secondary outcomes
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
Amnesia
Time frame: At inclusion
SCAT
Time frame: At inclusion
Sleep
Time frame: At inclusion
Consciousness
Time frame: At inclusion
Position
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiphaine Vidal principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests in people with Concussion, Brain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alertness time (time frame: At inclusion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.