Effects of Soccer Heading on Ocular-motor Function and Blood Biomarker
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03488381 |
Recruitment Status :
Completed
First Posted : April 5, 2018
Last Update Posted : April 17, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trauma, Head | Device: Soccer Heading | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Effects of Repetitive Subconcussive Head Impacts on Ocular-motor Function and Brain-derived Blood Biomarker |
Actual Study Start Date : | August 1, 2017 |
Actual Primary Completion Date : | April 9, 2019 |
Actual Study Completion Date : | April 9, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: 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. Other Name: Soccer Kicking |
Sham Comparator: Kicking-Control |
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. Other Name: Soccer Kicking |
- Changes in Brain-Derived Blood Biomarker Over Time in Relation to the Baseline [ Time Frame: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post) ]Outcome measure will be the slope of increased (worsened) levels of blood biomarkers compared to the baseline and control group
- Changes in Ocular-Motor Function Over Time in Relation to the Baseline [ Time Frame: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post) ]Outcome measure will be the slope of increased (worsened) levels of ocular-motor performance compared to the baseline and control group

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 26 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For Soccer Cohort
- 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.
For non-Athletic Control Cohort
- Being between 18 to 26 years of age
- Have never played organized sports
- Have never been diagnosed with a concussion
Exclusion Criteria:
For both Soccer and Non-Athletic Control cohorts
- any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
- 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
- metal implants in the head
- implantation of cochlear device, cardiac pacemaker, medical fusion device, intracardiac lines, or neurostimulator (e.g., DBS, epidural/subdural VNS)
-
history of severe injury to the bones, joints, or muscles in either arm
Session-specific exclusion criteria will include:
- slept less than 4 hours before the 1st and 2nd test day (verified by the TMS screening questionnaire)
- drank more than 3 alcoholic drinks or used recreational drugs 24 hours before the 1st and 2nd test day
- drank more than 3 cups of coffee in an hour before test sessions
- glasses are prohibited (contact lens are okay) for safety purpose for the heading intervention

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488381
United States, Indiana | |
Indiana University | |
Bloomington, Indiana, United States, 47405 |
Documents provided by Keisuke Kawata, Indiana University:
Responsible Party: | Keisuke Kawata, Assistant Professor of Kinesiology, Indiana University |
ClinicalTrials.gov Identifier: | NCT03488381 |
Other Study ID Numbers: |
1610743422 |
First Posted: | April 5, 2018 Key Record Dates |
Last Update Posted: | April 17, 2019 |
Last Verified: | April 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Craniocerebral Trauma Trauma, Nervous System Nervous System Diseases Wounds and Injuries |