Concussion, MildAUSSIE-2NCT05771051
Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)
An observational study of Concussion, Mild, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Headpulse measurements
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- head laceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2
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.
Read the 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 from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm
- Conditions
- Concussion, Mild
- Being tested
- Headpulse measurements
- Keywords
- headpulse, mTBI
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headpulse measurementsDevice
Also called Wrist accelerometer
Placement of headset on subject
| Study group | Role | What they receive |
|---|---|---|
| Concussed | Diagnosis of concussion Receives: Device: Headpulse measurements | |
| Controls | Athletes with no concussion with the preceding year Receives: Device: Headpulse measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of model for the detection of concussion
Sensitivity of headpulse measurements confirming concussion
Measured: 1 month
Secondary outcomes (1)
Time to recovery of headpulse following concussion
Time (hours) when the headpulse biometric returns to within 1 SD of normal values
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Mar 2022
- Primary completion2 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wade S Smith, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771051
- Sponsor's protocol ID
- 1573
- Acronym
- AUSSIE-2
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2
- ClinicalTrials.gov ID
- NCT05771051
- Acronym / sponsor ID
- AUSSIE-2 / 1573
- Conditions
- Concussion, Mild
- Keywords
- headpulse, mTBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed | – | Device: Headpulse measurementsDiagnosis of concussion |
| Controls | – | Device: Headpulse measurementsAthletes with no concussion with the preceding year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (8 listed)
- Diagnosed with sport related concussion
- first recording obtained within one week
- willingness to have multiple recordings in the month following concussion
- head laceration
- athletes without concussion over the last year
Key exclusion criteria (1 listed)
- head laceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headpulse measurementsAlso: Wrist accelerometerPlacement of headset on subject | Device | Concussed, Controls |
Primary outcome
Accuracy of model for the detection of concussion
Time frame: 1 month
Sensitivity of headpulse measurements confirming concussion
1 secondary outcome
Time to recovery of headpulse following concussion
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade S Smith, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of model for the detection of concussion (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.