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

Concussion, Mild Clinical Trial

— AUSSIE-2  

Official title:

Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771051
• Other study ID #: 1573
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 1, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

Device:
• Headpulse measurements
Placement of headset on subject

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of model for the detection of concussion	Sensitivity of headpulse measurements confirming concussion	1 month
Secondary	Time to recovery of headpulse following concussion	Time (hours) when the headpulse biometric returns to within 1 SD of normal values	1 Month