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

NCT ID: NCT05771051

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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

Conditions

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Concussion, Mild

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Concussed

Diagnosis of concussion

Headpulse measurements

Intervention Type DEVICE

Placement of headset on subject

Controls

Athletes with no concussion with the preceding year

Headpulse measurements

Intervention Type DEVICE

Placement of headset on subject

Interventions

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Headpulse measurements

Placement of headset on subject

Intervention Type DEVICE

Other Intervention Names

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Wrist accelerometer

Eligibility Criteria

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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:


* athletes without concussion over the last year
* willingness to have single or multiple recordings

Exclusion Criteria

* head laceration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wade S Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1573

Identifier Type: -

Identifier Source: org_study_id

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