N/A
Completed N=72
Concussion Prevention in Female Soccer Athletes
Concussion, Mild · Concussion, Brain
Source: ClinicalTrials.gov NCT03014492 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Pre-season to Post-season DTI Percentage Change — -0.17; -1.27; 0.45; 2.83 percentage of change
Summary
The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-season to Post-season DTI Percentage Change |
-0.17; -1.27; 0.45; 2.83; 0.37; 2.58 | — |
| PRIMARY Number of Participants Completing EEG |
44; 28 | — |
Eligibility Criteria
Inclusion Criteria
- Female
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on a high school soccer team
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03014492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.