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Completed

NCT Number: NCT05771051

Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)

Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF

San Francisco, California, 94143, United States

About this study

Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Concussion Subjects:

Inclusion criteria

  • Diagnosed with sport related concussion
  • first recording obtained within one week
  • willingness to have multiple recordings in the month following concussion

Exclusions:

  • head laceration

Control subjects:

Inclusion criteria

  • athletes without concussion over the last year
  • willingness to have single or multiple recordings

Exclusion criteria

  • head laceration

Treatment and study plan

Headpulse measurements

Device

Placement of headset on subject

Other names: Wrist accelerometer

Primary outcomes

  1. Accuracy of model for the detection of concussion

    Time frame: 1 month

    Sensitivity of headpulse measurements confirming concussion

Secondary outcomes

  1. Time to recovery of headpulse following concussion

    Time frame: 1 Month

    Time (hours) when the headpulse biometric returns to within 1 SD of normal values

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2

Acronym: AUSSIE-2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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