NCT05769296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 3, 2023

Last Update Submit

March 14, 2023

Conditions

Concussion, Mild

Keywords

mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Feasibility of subject recruitment

    2.5 months

Study Arms (2)

Concussed

Diagnosis of concussion

Device: Headpulse measurements

Controls

Athletes with no concussion within the preceding year

Device: Headpulse measurements

Interventions

Headpulse measurementsDEVICE

Placement of headset on subject

ConcussedControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosed with sport related concussion
  • first recording obtained within one week
  • willingness to have multiple recordings in the month following concussion
  • \- head laceration
  • Control subjects:
  • athletes without concussion over the last year
  • willingness to have single or multiple recordings

You may not qualify if:

  • \- head laceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Wade S Smith, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

June 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)