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

March 14, 2023 updated by: University of California, San Francisco

Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of model for the detection of concussion
Time Frame: 1 month
Sensitivity of headpulse measurements confirming concussion
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Concussion, Mild

Clinical Trials on Headpulse measurements

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe