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CompletedNCT05771051AUSSIE-2Updated Mar 16, 2023

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

An observational study in Concussion, Mild, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
68
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Concussion, Mild

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Keywords

  • headpulse
  • mTBI
03

In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's enrollment of 68 is below the median of 180 across 146 observational studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Recently concussed athletes playing Australian rules football. Controls are athletes of Australian Football or other sports without concussion for more than 1 year.

Eligibility criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No

Groups and cohorts

  • Concussed

    Diagnosis of concussion

    Device: Headpulse measurements

  • Controls

    Athletes with no concussion with the preceding year

    Device: Headpulse measurements

Interventions

  • DeviceHeadpulse measurements

    Placement of headset on subject

    Also known as: Wrist accelerometer

06

What researchers measure

Primary outcomes

  1. Accuracy of model for the detection of concussion

    Sensitivity of headpulse measurements confirming concussion

    Time frame: 1 month

Secondary outcomes

  1. Time to recovery of headpulse following concussion

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

    Time frame: 1 Month

07

Study locations

1 site
  • UCSF
    San Francisco, California 94143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05771051
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Mar 1, 2022
Primary completion
Sep 2, 2022
Completion
Oct 1, 2022
Last update
Mar 16, 2023

Study contacts

Wade S Smith, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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