RHI Interval Effects on Brain Health

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07010887
Status
Recruiting
Apply to this trial

Conditions

  • Repetitive Head Impacts

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Short Interval — OTHER
    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 — OTHER
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Blood Biomarkers - NfL [ Time Frame: Baseline, 24 hours following the final heading session, 14 days following the final heading session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of Public HealthBloomingtonIndiana47405
Keisuke Kawata
[email protected]
812-855-5244
Keisuke Kawata, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University School of Public Health· Bloomington, IN

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