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Effects of Soccer Heading on Ocular-motor Function and Blood Biomarker

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ClinicalTrials.gov Identifier: NCT03488381
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Keisuke Kawata, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Trauma, Head Device: Soccer Heading Not Applicable

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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




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Soccer Cohort

  1. being between 18 to 26 years of age
  2. an active member of a soccer team (i.e., collegiate, intramural, club, professional)
  3. at least 5 years of soccer heading experience.

For non-Athletic Control Cohort

  1. Being between 18 to 26 years of age
  2. Have never played organized sports
  3. Have never been diagnosed with a concussion

Exclusion Criteria:

For both Soccer and Non-Athletic Control cohorts

  1. any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
  2. history of vestibular, ocular, or vision dysfunction (e.g., macular degeneration)
  3. currently taking any medications affecting balance (e.g., antibiotics)
  4. pregnancy
  5. HIV
  6. 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)
  7. hypertension, cardiac arrhythmia, or pulmonary disease
  8. lower extremity injury that would prohibit normal walking
  9. metal implants in the head
  10. implantation of cochlear device, cardiac pacemaker, medical fusion device, intracardiac lines, or neurostimulator (e.g., DBS, epidural/subdural VNS)
  11. history of severe injury to the bones, joints, or muscles in either arm

    Session-specific exclusion criteria will include:

  12. slept less than 4 hours before the 1st and 2nd test day (verified by the TMS screening questionnaire)
  13. drank more than 3 alcoholic drinks or used recreational drugs 24 hours before the 1st and 2nd test day
  14. drank more than 3 cups of coffee in an hour before test sessions
  15. glasses are prohibited (contact lens are okay) for safety purpose for the heading intervention

Information from the National Library of Medicine

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


Locations
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United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
  Study Documents (Full-Text)

Documents provided by Keisuke Kawata, Indiana University:
Study Protocol  [PDF] January 9, 2018
Informed Consent Form  [PDF] January 9, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries