- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03914833
Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery (EXAECOS)
November 24, 2021 updated by: Centre Hospitalier Universitaire Dijon
Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dijon, France, 21079
- Chu Dijon Bourgogne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 25 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients consulting at the CMRR of the CHU Dijon Bourgogne
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients
Patients aged 13 to 25 years old with a concussion in sports practice less than 72 hours previously
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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)
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Control - High-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
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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)
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Control - Non-high-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
|
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reaction time on the TAP computerized battery
Time Frame: Through study completion, an average of 23 month
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Through study completion, an average of 23 month
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Number of errors on the TAP computerized battery
Time Frame: Through study completion, an average of 23 month
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Through study completion, an average of 23 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 28, 2019
Primary Completion (ACTUAL)
March 10, 2020
Study Completion (ACTUAL)
March 10, 2020
Study Registration Dates
First Submitted
April 12, 2019
First Submitted That Met QC Criteria
April 12, 2019
First Posted (ACTUAL)
April 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- BEJOT 2018-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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