Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and You… (NCT03914833) | Clinical Trial Compass
CompletedNot Applicable
Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery
France72 participantsStarted 2019-03-28
Plain-language 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.
Who can participate
Age range
13 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reaction time on the TAP computerized battery
Timeframe: Through study completion, an average of 23 month
2
Number of errors on the TAP computerized battery
Timeframe: Through study completion, an average of 23 month