Detection and Prevention of Concussive Injuries With Smart Technology.

NCT04946747 | Unknown

• 1 other identifier: 19-013
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.
2. 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.

Conditions

Concussion; Head Injury Trauma

Keywords

Soccer; Concussion; Traumatic Brain Injury; Sports Injury; Head Impact; Concussion Risk Assessment; Modern microelectrical mechanical systems

Outcome Measures

Primary Outcomes (3)

• Examine the accuracy of our sensors in setting personalized concussive thresholds.

  We aim to capture data on head impact events or head movements from male and female human subjects. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. These data we will assess includes head angular velocities and accelerations. When such data is processed and assessed, we can query the data with our machine-learning algorithms in order to derive data on putative concussive threshold. The results of such queries will inform us whether concussive threshold may have a gender-specific component.

  3 months

• Monitor neck stiffness of participants in 2 groups (Trained versus Control) while using virtual reality goggles.

  We aim to monitor neck stiffness of participants in 2 groups. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. More specifically, if a pair of such sensors are affixed to a human subject, we can assess, compare, and compute from the outputs (on head angular velocities and accelerations) of the pair and determine the relative discrepancies between the output of the pair. The stiffness measure, including neck stiffness, is inversely proportional to the amount of the said discrepancies described above. The results of such comparison and computation will therefore inform us whether neck stiffness can be modified by training with virtual reality goggles.

  3 months

• Optimize and finalize our training protocol

  We aim to train human subjects in stiffing the neck prior to impact. The impact will be delivered in virtual reality such that the human subject is not getting a real impact. Participants in training will nevertheless acquire the neck-stiffening reflex upon "sensing" the impact in virtual reality. We, as investigators, will monitor the data on neck stiffness as described previously in our reply to comment 2. One goal of such monitoring is for us to optimize our detailed training protocol. As before in comments 1 and 2, the name of the measurement tool is accelerometers or inertia measurement unit (IMU). The expected outcome is that in the two groups of human subjects (trained vs. control as described in comment 2), the trained group will show significantly increases in neck stiffness upon impact compared with the control group.

  5 months

Study Arms (2)

Trained

ACTIVE COMPARATOR

Both groups will be shown how to use the Virtual Reality goggles. 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. Both groups will also wear our smart head-impact sensor system to measure their response to training.

Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors; Other: Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus

Control

ACTIVE COMPARATOR

Both groups will be shown how to use the Virtual Reality goggles. The Control group will also receive the same CS and the same US, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training.

Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors; Other: Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus

Interventions

Modern microelectrical mechanical systems (MEMS) head-impact sensors DEVICE

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

Control; Trained

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

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.

Also known as: Virtual Reality (VR) Goggle use/experience

Trained

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

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.

Also known as: Virtual Reality (VR) Goggle use/experience

Control

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Local soccer academy soccer player, Age 7-17,
• Agrees to participate in study, (signed Assent),
• Parent agrees to child's participation in study (signed consent)

You may not qualify if:

• Any individual who does not agree to participate,
• Any individual whose parent does not agree to having their child participate,
• Individual who is unable or unwilling to wear a sensor

Sponsors & Collaborators

• Chi-Ming Huang: lead
• UMKC School of Medicine: collaborator

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Athletic Injuries

Interventions

Micro-Electrical-Mechanical Systems

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Kim Dyer, MSN

CONTACT

816.404.1380; kim.dyer@tmcmed.org

Chiming Huang, PhD

CONTACT

HuangC@umkc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, UMKC School of Biology & Chemistry

Model Details: Participants will be randomized into 2 groups -- Trained group and Control group.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: July 1, 2021
• Study Start: June 1, 2021
• Primary Completion: December 17, 2021
• Study Completion: April 10, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share