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NCT04426188: Soccer-BRAIN
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
NA trial testing Heading series in Traumatic Brain Injury in 21 participants. Completed in 15 January 2021.
7 October 2020
Quick facts
| Lead sponsor | University Hospital, Bordeaux |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 21 |
| Start date | 4 June 2020 |
| Primary completion | 7 October 2020 |
| Estimated completion | 15 January 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Heading series
- Magnetic Resonance Imaging (MRI)
- Cognitive computerized assessment
- Electrophysiological records
- Dynamometer
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Concussion, Brain — all drugs for Concussion, Brain →
Sponsor
University Hospital, Bordeaux
Who can join
Adults 18 to 25, male only, with Traumatic Brain Injury or Concussion, Brain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04426188
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04426188 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
- Last refreshed: 29 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04426188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing