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Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery (EXAECOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914833
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
Concussion in sports ("Sports-Related Concussion" or "SRC") are a public health issue. The management of these injuries is evolving rapidly and decisions to return to play are based on clinical judgment. It is now recognized that the assessment of cognitive function must be one of the components of the assessment, in particular, in the protocol used to decide if a patient can resume practice. The available scales include only a brief cognitive assessment but do not provide an understanding of the level of deficit treatment. The use of computerized TAP (Test of Attentionnal Performance) tests, including finer measures of reaction time and apprehending the different attention and executive components (alertnes, orientation, flexibility, inhibition, updating), would allow a better understanding of the nature of the disorder and link it to subjective symptoms, and recovery.

Condition or disease Intervention/treatment
Sports-related Concussion Other: Inclusion Questionnaires Other: Questionnaires at inclusion, M1 and M3

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery.
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Group/Cohort Intervention/treatment
Patients
Patients aged 13 to 25 years old with a concussion in sports practice less than 72 hours previously
Other: Questionnaires at inclusion, M1 and M3
During the inclusion visit, the 1-month visit and the 3-month visit; neuropsychologist grading of the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Index) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)

Control - High-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
Other: Inclusion Questionnaires
During the inclusion visit, neuropsychologist tests the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Scale) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)

Control - Non-high-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
Other: Inclusion Questionnaires
During the inclusion visit, neuropsychologist tests the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Scale) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)




Primary Outcome Measures :
  1. Reaction time on the TAP computerized battery [ Time Frame: Through study completion, an average of 23 month ]
  2. Number of errors on the TAP computerized battery [ Time Frame: Through study completion, an average of 23 month ]


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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting at the CMRR of the CHU Dijon Bourgogne
Criteria

Inclusion Criteria:

  • Person who has given his non-opposition
  • For minor controls: Written authorization and non-opposition from the 2 holders of parental authority beforehand.
  • For minor patients: non-opposition from the 2 holders of parental authority
  • For patients: patients aged 13 to 25 years old who have suffered a concussion in sports practice less than 72 hours previously and who consult at the CMRR of the CHU Dijon Bourgogne
  • For controls: healthy subjects aged 13 to 25 years old students in one of the partner schools (Lycée les Arcades de Dijon, Lycée Saint Joseph, Dijon; Collège Marcel Pardé, Dijon; CREPS (Centre de Ressources et d'Expertise à la Performance Sportive) who have not had a concussion.

Exclusion Criteria:

  • Person subject to legal protection (curatorship, guardianship)
  • Person subject to limited judicial protection
  • Pregnant, parturient or breastfeeding woman
  • Major unable to consent
  • For controls: subjects with a history of learning disabilities and/or concussion (identification of this history on the SCAT3 inclusion questionnaire).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914833


Contacts
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Contact: Yannick BEJOT +33 3 80 29 57 80 yannick.bejot@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Contact: Yannick BEJOT    3.80.29.57.80 ext 33    yannick.bejot@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03914833    
Other Study ID Numbers: BEJOT 2018-2
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No