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Clinical Trials/NCT05769296
NCT05769296
Completed
Not Applicable

Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry

University of California, San Francisco1 site in 1 country34 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion, Mild
Sponsor
University of California, San Francisco
Enrollment
34
Locations
1
Primary Endpoint
Sensitivity of headpulse measurements to detect subjects with concussion
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
October 1, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity of headpulse measurements to detect subjects with concussion

Time Frame: 1 month

Proportion of clinically concussed athletes that have headpulse values \> 2SD of control subjects

Secondary Outcomes

  • Feasibility of subject recruitment(2.5 months)

Study Sites (1)

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