Effects of Soccer Heading on Ocular-motor Function and Blood Biomarker (NCT03488381) | Clinical Trial Compass
CompletedNot Applicable
Effects of Soccer Heading on Ocular-motor Function and Blood Biomarker
United States45 participantsStarted 2017-08-01
Plain-language summary
Repetitive head impacts in sports and military may cause deleterious effects in the nervous system. Investigators' previous works in football players have shown promising results in prediction of concussion and prevention of long-term defect using eye-movement paradigm (ocular-motor system) and blood biomarker. However, acute head impact effects on aforementioned parameters remain unknown. Thus, to answer a critical research question that whether or not ocular-motor system and brain-derived blood biomarker may be acutely altered following 10 successions of controlled soccer heading. To answer the question, investigators hypothesized that acute bout of soccer heading will not elicit noticeable change in subject's symptoms but to induce a transient defect in the ocular-motor system and increase plasma expression of brain-derived biomarker.
Who can participate
Age range
18 Years – 26 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. being between 18 to 26 years of age
. an active member of a soccer team (i.e., collegiate, intramural, club, professional)
. at least 5 years of soccer heading experience.
. Being between 18 to 26 years of age
. Have never played organized sports
. Have never been diagnosed with a concussion
Exclusion criteria
. any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked changes in blood biomarkers and eye movement function specifically after soccer heading — if I or my child plays soccer, what do my current biomarker levels or eye movement test results look like compared to what this study found at baseline?
2Since this trial has already been completed, has my doctor seen the published results, and do those findings change any recommendations about how frequently heading should be done during practice or games?
3The study measured ocular-motor function changes over time after heading — are there any eye movement symptoms or visual tracking problems I should be watching for that might suggest something worth evaluating?
4This was listed as phase 'not applicable,' which often means it's an observational or measurement study rather than a treatment trial — does that mean the findings are more about understanding risk than offering a specific intervention, and what would the next step be if a problem was detected?
5Given that this study focused on head trauma from a repeated, low-impact activity like soccer heading, how does this compare to what my doctor already knows about my specific head trauma history, and should I get any of the same biomarker or eye movement testing done?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Brain-Derived Blood Biomarker Over Time in Relation to the Baseline
Timeframe: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
2
Changes in Ocular-Motor Function Over Time in Relation to the Baseline
Timeframe: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
. history of vestibular, ocular, or vision dysfunction (e.g., macular degeneration)
. currently taking any medications affecting balance (e.g., antibiotics)
. pregnancy
. HIV
. any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, spinal cord injury/surgery, history of stroke)
. hypertension, cardiac arrhythmia, or pulmonary disease
. lower extremity injury that would prohibit normal walking