An interventional study of Soccer Heading in Trauma, Head, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
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Among 95 studies in Craniocerebral Trauma with a site in United States — 12 open to participants now, 17 under way, none of them phase 3. Craniocerebral Trauma · United States.
Among the 95 studies in Craniocerebral Trauma with a site in United States, this one is the 41st largest by enrollment of the 61 interventional ones that give a count, is one of 7 that started in 2017, is one of 50 with no phase, and was the 57th registered.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
Browse Craniocerebral Trauma studies →12 of the 95 studies in Craniocerebral Trauma with a site in United States are open now. Recruiting first, the newest first:
Northern California Institute of Research and Education · Sites in United States
Ages 50–89
Wake Forest University Health Sciences · Sites in United States
Ages up to 18
New York Institute of Technology · Sites in United States
Ages 18–50 · Healthy volunteers
University of California, Davis · Sites in United States
Ages 11–17
VA Office of Research and Development · Sites in United States
Ages 22–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 26 Years · all sexes · healthy volunteers too.
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95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 4 · Phase 3 4 · Phase 4 2
First in 1983; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is below the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Median enrollment 94 across the 61 interventional studies, 192 across the 33 observational. Of the 69 that completed or were terminated, 17 (25%) have results posted.
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9 of 95 have an industry lead sponsor. The 10 most frequent:
Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Indiana University has 1 study filed under Craniocerebral Trauma — fewer than ten, so there is no comparison to draw.
3 of the studies in Craniocerebral Trauma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06632587Thomas Jefferson UniversityTiming Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes | 2026-12-01 |
| NCT06697808Wake Forest University Health SciencesCranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics | 2027-04 |
| NCT05663034Johns Hopkins UniversityCBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms | 2027-06 |
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Among the 95 studies in Craniocerebral Trauma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Adult aged soccer players aged 18-26 years will be recruited via listserv email to Indiana University undergraduate students. Once subjects fulfill inclusion criteria and free of exclusion criteria, participants will be randomly assigned to one of two groups (Heading vs. Kicking).
For non-athletic control cohort, investigators will attempt to recruit 20 subjects who are 18-26 years old, have never played organized sports, and have never been diagnosed with a concussion before. This cohort is to evaluate and account for the soccer players' baseline, which may be influenced by a history of repetitive heading and sports participation. This group will participate in a single test session that lasts approximately in 1.5 hours. During the session, blood draw (4mL, about 1 teaspoon), measure eye movements using an ocular motor headset,
The study consists of 4 data collection time points in a 2-day period. This study design will enable to test outcome measures over 3 acute phases.
A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer (Triax Technologies) embedded in a head-band pocket and positioned back of the head to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph across both groups. Soccer players frequently perform this maneuver during practice and game. Subjects will stand approximately 40ft away from the machine to perform either the heading or kicking. Participants in the heading group perform 10 standing headers with 1 header per minute, whereas kicking control group performs 10 kicks. The participants in the heading and kicking groups will be instructed to direct the ball back toward the JUGS soccer machine in the air.
During each test session, various assessments will be conducted on each subject. First, the post-concussion symptom scale, as a subset of the Sports Concussion Assessment Tool 3, will be used as a method of assessing the presence and severity of symptoms. This paper-pencil symptom checklist consists of 22 symptoms with 7-point Likert scale per symptom to monitor subject's well-being. Next, Antecubital vein blood draws will be performed each test session to help determine blood biomarker concentrations. A certified phlebotomist will thoroughly clean the elbow surface with an alcohol swab and draw 4 ml of whole blood (approx. 1 teaspoon) into vacutainer tubes containing EDTA anti-coagulant with 21G butterfly needle. A Total of 16 ml blood for the study (4 ml x 4 time points; 3\~4 teaspoons). After the blood draw, the subject will use gauze to maintain direct pressure for 3 mins and Band-Aid will be provided. The whole blood will be centrifuged at 3,000 revolutions per minute for 20 minutes at 4°C after 40 mins of coagulation. The plasma will then be divided and transferred into 1 mL cryovials and flash frozen and stored at -80°C in Exercise Biochemistry lab.
The subject will then perform eye-movement tasks using the EYE-SYNC headset. This visual-tracking protocol has been replicated and validated in a number of concussion and sleep deprivation studies, however to investigators' knowledge this study for the first time will unravel subconcussive effects. Prior to testing, a Snellen chart will be used to verify that the subject has a normal or corrected-to-normal vision (minimum 20/30). The subject will be seated in a normally lit room and stabilize the headset with two hands while the elbows placed on the desk. The visual stimulus will be presented using a 120-Hz frame rate LCD screen in the headset and binocular eye movements will be tracked by a single camera secured in the headset. The test stimulus consists of a red circular target, 0.5° diameter in a visual angle with a 0.2° black dot in the center. The target moves in a circular clockwise trajectory of 10° radius at 0.4 Hz, with the target speed corresponding to 25°/s. The entire testing sequence will last approximately 3 mins consisted of a calibration and 2 consecutive test runs. Calibration of the eye position is conducted by having the subject fixate on a target presented at eight locations on the circular path of the test stimulus and one additional fixation point at the center of the circular path. The fixation target was presented at these nine locations in a randomized order. Each of the two test runs consists of 6 cycles of circular movement corresponding to 15 s in duration per test run. The subject will be instructed as "follow the movement of the target as closely as possible."
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For Soccer Cohort
For non-Athletic Control Cohort
Exclusion Criteria:
For both Soccer and Non-Athletic Control cohorts
history of severe injury to the bones, joints, or muscles in either arm
Session-specific exclusion criteria will include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Soccer Heading
Device: Soccer Heading
Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 10 consecutive soccer headings, separated by one minute intervals. Soccer Kicking: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 10 consecutive soccer kicks, separated by one minute intervals.
Also known as: Soccer Kicking
Changes in Brain-Derived Blood Biomarker Over Time in Relation to the Baseline
Outcome measure will be the slope of increased (worsened) levels of blood biomarkers compared to the baseline and control group
Time frame: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
Changes in Ocular-Motor Function Over Time in Relation to the Baseline
Outcome measure will be the slope of increased (worsened) levels of ocular-motor performance compared to the baseline and control group
Time frame: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2017 to primary completion in Apr 2019, 20 months.
Of 50 non-industry interventional studies with no phase under Craniocerebral Trauma, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's 20 months is below that.
Counting every sponsor, half of 51 studies reached it within 26 months; a quarter within 11 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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