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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT05771051
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Concussion, Mild	Device: Headpulse measurements

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 Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Sep 2, 2022
• Actual Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Concussed Diagnosis of concussion	Device: Headpulse measurements; Placement of headset on subject; Other Names: Wrist accelerometer
Controls Athletes with no concussion with the preceding year	Device: Headpulse measurements; Placement of headset on subject; Other Names: Wrist accelerometer

Outcome Measures

Primary Outcome Measures

1. Accuracy of model for the detection of concussion [1 month]

   Sensitivity of headpulse measurements confirming concussion

Secondary Outcome Measures

1. Time to recovery of headpulse following concussion [1 Month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Wade S Smith, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05771051
• Other Study ID Numbers: 1573
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, San Francisco: headpulse; mTBI
• Additional relevant MeSH terms: Brain Concussion

Study Results

No Results Posted as of Mar 16, 2023