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

Completed

• Conditions: Concussion, Mild
• Interventions: Device: Headpulse measurements

• Registration Number: NCT05771051
• Lead Sponsor: University of California, San Francisco

Brief 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.

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

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-09-02
• Study Completion: 2022-10-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concussed	Headpulse measurements	Diagnosis of concussion
Controls	Headpulse measurements	Athletes with no concussion with the preceding year

Primary Outcome Measures

Name	Time	Method
Accuracy of model for the detection of concussion	1 month	Sensitivity of headpulse measurements confirming concussion

Secondary Outcome Measures

Name	Time	Method
Time to recovery of headpulse following concussion	1 Month	Time (hours) when the headpulse biometric returns to within 1 SD of normal values

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States