Status:
COMPLETED
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Traumatic Brain Injury
Concussion, Brain
Eligibility:
MALE
18-25 years
Phase:
NA
Brief Summary
Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer invo...
Eligibility Criteria
Inclusion
- Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux
Exclusion
- Abnormal neurological examination
- Taking drugs targeting the central nervous system
- Any unhealed injury
- History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
- Family history of epilepsy
- Contraindication to MRI: head circumference\> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body - refusal to be informed of an anomaly detected with MRI
- Individuals under legal protection or unable of giving their informed consent
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04426188
Start Date
June 4 2020
End Date
January 15 2021
Last Update
March 29 2021
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33 076