Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery
EXAECOS
1 other identifier
observational
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2019
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedNovember 26, 2021
November 1, 2021
12 months
April 12, 2019
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Reaction time on the TAP computerized battery
Through study completion, an average of 23 month
Number of errors on the TAP computerized battery
Through study completion, an average of 23 month
Study Arms (3)
Patients
Patients aged 13 to 25 years old with a concussion in sports practice less than 72 hours previously
Control - High-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
Control - Non-high-level athelete
healthy subjects aged 13 to 25 years students at one of the partner institutions
Interventions
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)
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)
Eligibility Criteria
Patients consulting at the CMRR of the CHU Dijon Bourgogne
You may qualify if:
- 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.
You may not qualify if:
- Person subject to legal protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnant, parturient or breastfeeding woman
- Major unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21079, France
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
March 28, 2019
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
November 26, 2021
Record last verified: 2021-11