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

NCT03488381 | Completed

• 1 other identifier: 1610743422
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Head

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)

Study Arms (2)

Soccer Heading

EXPERIMENTAL

Device: Soccer Heading

Kicking-Control

SHAM COMPARATOR

Device: Soccer Heading

Interventions

Soccer Heading DEVICE

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

Kicking-Control; Soccer Heading

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Related Publications (3)

• Huibregtse ME, Nowak MK, Kim JE, Kalbfell RM, Koppineni A, Ejima K, Kawata K. Does acute soccer heading cause an increase in plasma S100B? A randomized controlled trial. PLoS One. 2020 Oct 23;15(10):e0239507. doi: 10.1371/journal.pone.0239507. eCollection 2020.

  PMID: 33096545 DERIVED

• Huibregtse ME, Ejima K, Chen Z, Kalbfell RM, Koppineni A, Kawata K. Acute Time-Course Changes in CCL11, CCL2, and IL-10 Levels After Controlled Subconcussive Head Impacts: A Pilot Randomized Clinical Trial. J Head Trauma Rehabil. 2020 Sep/Oct;35(5):308-316. doi: 10.1097/HTR.0000000000000597.

  PMID: 32881764 DERIVED

• Nowak MK, Bevilacqua ZW, Ejima K, Huibregtse ME, Chen Z, Mickleborough TD, Newman SD, Kawata K. Neuro-Ophthalmologic Response to Repetitive Subconcussive Head Impacts: A Randomized Clinical Trial. JAMA Ophthalmol. 2020 Apr 1;138(4):350-357. doi: 10.1001/jamaophthalmol.2019.6128.

  PMID: 32053162 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 5, 2018
• Study Start: August 1, 2017
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)