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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05771051
Other study ID # 1573
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date October 1, 2022

Study information

Verified date March 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 1, 2022
Est. primary completion date September 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Headpulse measurements
Placement of headset on subject

Locations

Country Name City State
United States UCSF San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of model for the detection of concussion Sensitivity of headpulse measurements confirming concussion 1 month
Secondary Time to recovery of headpulse following concussion Time (hours) when the headpulse biometric returns to within 1 SD of normal values 1 Month
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