RHI Interval Effects on Brain Health

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

Interventions

OTHER

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.

OTHER

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.

DEVICE

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• University of Rochester

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• University at Buffalo

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Keisuke Kawata, PhD · Indiana University Bloomington Department of Kineseology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-05

Primary Completion

2028-09-30

Completion

2028-09-30

FDA Device

Yes

Countries

• United States

Study Locations