Detection and Prevention of Concussive Injuries With Smart Technology.

NCT04946747 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-01

No results posted yet for this study

Summary

Concussions are consequences of inopportune interactions between an impact force and the head that causes the head (and brain) to move too rapidly. This project involves two parts.

1. The outcome of head-impact depends upon the force and the biomechanical properties of the head-and-neck. Modern microelectrical mechanical systems (MEMS) head-impact sensors only measure the physical parameters of external forces. The researchers have developed a next-generation smart MEMS sensor fortified with artificial intelligence (AI) that can help define a personalized concussive threshold.

The researchers sensor machine-learns the biomechanical properties of the participant's head-and-neck and accurately determines the likelihood for concussive injuries. The researchers first goal is to field-test the sensor in soccer players.
2. Researchers hypothesize that an increase in neck stiffness should reduce concussive risks. The researchers have developed a training protocol that involves a conditioned response (CR) to increase neck stiffness during a head-impact event and thereby decrease concussion risk. The Researchers have also developed technology to monitor neck stiffness.

The smart sensor is fully integrated into the training protocol and monitors the neck stiffness to validate the effectiveness of the training. The second goal is to optimize and finalize our training protocol and conduct a field-test in soccer players.

Conditions

  • Concussion
  • Head Injury Trauma

Interventions

DEVICE

Modern microelectrical mechanical systems (MEMS) head-impact sensors

Both groups will wear our smart head-impact sensor system (MEMS head-impact sensors) to measure their response to training.

OTHER

Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus

The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge.

OTHER

Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus

The Control group will also receive the same CS and the same US as trained group, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge.

Sponsors & Collaborators

  • UMKC School of Medicine

    collaborator UNKNOWN
  • Chi-Ming Huang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-12-17
Completion
2022-04-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946747 on ClinicalTrials.gov