Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04426188
Other study ID # CHUBX 2019/45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2020
Est. completion date January 15, 2021

Study information

Verified date March 2021
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 15, 2021
Est. primary completion date October 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux Exclusion Criteria: - 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

Study Design


Intervention

Procedure:
Heading series
10 headers from machine-projected soccer balls at standardized speeds
Device:
Magnetic Resonance Imaging (MRI)
Brain MRI before and after a series
Other:
Cognitive computerized assessment
Cognitive evaluation carried out with two computerized tools
Procedure:
Electrophysiological records
Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG)
Device:
Dynamometer
Measure of the strength of the neck muscles using a dynamometer

Locations

Country Name City State
France CHU de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean acceleration (m/s²) Mean linear and rotational acceleration of the head Week 4
Primary Mean acceleration (m/s²) Mean linear and rotational acceleration of the head Week 6
Secondary Period of cortical silence (milliseconds) Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings. Week 4
Secondary Period of cortical silence (milliseconds) Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings. Week 6
Secondary Normalized score Normalized score (Z-score) on the subtests of the computerized cognitive battery Week 4
Secondary Normalized score Normalized score (Z-score) on the subtests of the computerized cognitive battery Week 6
Secondary Average time Average time on the subtests of the computerized cognitive battery Week 4
Secondary Average time Average time on the subtests of the computerized cognitive battery Week 6
Secondary Mean strength ratio (Newton) Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer Week 4
Secondary Mean strength ratio (Newton) Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer Week 6
Secondary T-size measure Functional connectivity at rest in MRI Week 4
Secondary T-size measure Functional connectivity at rest in MRI Week 6
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1