Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

Completed · Not applicable

Conditions studied: MTBI - Mild Traumatic Brain Injury, Concussion, Mild

In brief

The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: * Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. * Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.

Key facts

Study ID

NCT04068883

Run by

Children's Hospital Medical Center, Cincinnati

People needed

488

Starts

2018-07-01

Expected to finish

2019-06-30

Last updated by the study team

2020-08-24

Who can join

Age: 13 and older, up to 19. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal healthy volunteer
• Able to provide written consent
• Must be 13 years or older and a participant on a high school football or soccer team

You may not qualify if…

• Unable to provide written consent
• History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
• Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
• Glaucoma (Narrow Angle or Normal Tension)
• Hydrocephalus
• Recent penetrating brain trauma (within 6 months)
• Known carotid hypersensitivity
• Known increased intracranial pressure
• Central vein thrombosis
• Any known airway obstruction
• Any known seizure disorder
• Prothrombotic or hyperthrombotic condition
• Cerebral cavernous malformation
• Players not medically cleared to play sports

Where it is running

• Cincinanti Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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