Recruiting

Neurological Responses

Sponsor:

Indiana University

Code:

NCT07010887

Conditions

Repetitive Head Impacts

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Short Interval

Long Interval

BrainScope qEEG

Study Details

Brief summary:

Military service members frequently experience repetitive insults or impacts to the head (RHIs). The purpose of the proposed randomized controlled trial is to understand how time intervals affect neurological responses to repetitive subconcussive head impacts.

Conditions

Repetitive Head Impacts

Study ID

NCT07010887

Start date

Aug 5, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Current soccer player (intercollegiate, club, intramural, recreational).
  • At least 5 years of soccer heading experience (justification below).
  • Ability to provide informed consent without a legally authorized representative (LAR).

Exclusion Criteria:

  • Any head, neck, or face injury within the 6 months prior to enrollment, including concussions, that precludes participation in contact sports.
  • Participants with eye conditions or diseases that could impact the blood vessels in the eye -such as but not limited to: glaucoma, macular degeneration, diabetic retinopathy.
  • Determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the Investigator.

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Short Interval - heading

Participants in the heading group will undergo 16 soccer headings, twice per week, with 24 hours in between each session.

experimental: Long Interval - heading

Participants in the heading group will undergo 16 soccer headings, twice per week, with 72 hours in between each session.

sham comparator: Short Interval - kicking

Participants in the kicking-control group will undergo 16 soccer kicking, twice per week, with 24 hours in between each session.

sham comparator: Long Interval - kicking

Participants in the kicking-control group will undergo 16 soccer kicking, twice per week, with 72 hours in between each session.

Interventions

Short Interval

A standardized and reliable soccer heading protocol will be used for the experiment. Participants perform 16 headers or kicking with 1 header per 30 seconds. The sessions (twice per week for 4 weeks) will be separated by 24 hours.

Long Interval

A standardized and reliable soccer heading protocol will be used for the experiment. Participants perform 16 headers or kicking with 1 header per 30 seconds. The sessions (twice per week for 4 weeks) will be separated by 72 hours.

BrainScope qEEG

An Investigational version of the BrainScope FDA-cleared qEEG acquisition device will be used in this study. The investigational nature of the device is simply based on the code which does not produce a diagnostic result for the blinded researcher. Electrodes will be placed around the participant's forehead and scalp to acquire electrical readings of brain activity.

Primary outcome measure

  • Blood Biomarkers - NfL [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Blood Biomarkers - GFAP [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Blood Biomarkers - pTau [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Optical Coherence Tomography/Angiography (OCT/A) 1 [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Optical Coherence Tomography/Angiography (OCT/A) 2 [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Optical Coherence Tomography/Angiography (OCT/A) 3 [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]
  • Quantitative Electroencephalography (qEEG) [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]

Central Contacts and Locations

Central contacts

Keisuke Kawata, PhD

812-855-5244kkawata@indiana.edu

Blair Johnson, PhD

812-855-8699bj33@iu.edu

Locations

Indiana University School of Public Health

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Keisuke Kawata

812-855-5244kkawata@iu.edu

Principal Investigator:

Keisuke Kawata, PhD

More Information

Sponsor

Indiana University

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Subconcussive brain injury
  • TBI
  • Soccer Heading
  • Time Interval

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-04.