Australian UCSF Concussion in Athletes | NCT05769296

Studies
Australian UCSF Concussion in Athletes

NCT05769296

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Mar 17, 2023Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Concussion, Mild

Interventions

Headpulse measurements

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Mar 3, 2023

First Submission Date that Met QC Criteria

Mar 3, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 will be used to confirm prior models of analysis and produce a tool to be confirmed in a future study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concussed		Diagnosis of concussion	Device: Headpulse measurements
Controls		Athletes with no concussion within the preceding year	Device: Headpulse measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Headpulse measurements	Device	Placement of headset on subject	Concussed Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of headpulse measurements to detect subjects with concussion	Proportion of clinically concussed athletes that have headpulse values > 2SD of control subjects	1 month

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of subject recruitment	Number of subjects recruited during playoff season	2.5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wade S Smith, MD, PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF		San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion

Ancestor Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided