ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001707853

Ethics application status

Approved

Date submitted

9/11/2021

Date registered

13/12/2021

Date last updated

18/11/2022

Date data sharing statement initially provided

13/12/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Concussion in Sport- Head Pulse

Scientific title

Diagnostic Accuracy of Head Pulse Measurement for Concussion compared to the clinical diagnosis following head injury among Australian footballers.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1271-3433

Trial acronym

HPC

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Concussion

Brain Functionality After Concussion

Condition category

Condition code

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A head pulse device will be placed on the participant and a head pulse recording will be obtained. The duration of each recording is approximately 3-5 minutes, with the entire procedure including information gathering taking around 15 minutes.
For concussed participants, these tests will be conducted on game day at the venue that they are competing at.
Self report symptom inventory and neurobehavioural tests including Sport Concussion Assessment Tool (SCAT) questions will be completed and results will be entered into a secure database for analysis.
Concussed participants will be required to be tested daily for two weeks and then 3 times per week in weeks 3 and 4 after the concussion occurring, to measure their recovery.
Trained University Graduates will perform the testing.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Concussed participants will be measured and results compared with the brain functionality of non-concussed control participants.
The non-concussed participants will be tested 15 times throughout the 6 month study period, with the duration of each recording being 3-5 minutes. These tests will be conducted fortnightly at the training venue.
The Head Pulse recordings of the concussed participants will also be compared to the results of the standard Sport Concussion Assessment Tool (SCAT) test, which are performed by the teams medical staff as part of the diagnostic process in the moments immediately following the injury occurring.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of this interventional study is to document the diagnostic accuracy of the headpulse device for concussion compared to the clinical diagnosis for measurements made following injury.
Participants will have accelerometry measurements and concurrent 3 lead Electrocardiograms, with the main outcome measure being whether a characteristic waveform pattern of cranial accelerometry occurs with participants with concussion.

Timepoint [1]

Initial recording of concussed participant taken within 60 minutes of the injury occurring.
Daily recordings taken for 2 weeks following the injury.
3 recordings per week for weeks 3 and 4 following the injury.

Update reports will be prepared and reviewed by the researchers fortnightly, through the study period

Primary outcome [2]

A primary outcome of this observational study is to document the brain's recovery from concussion in the days immediately following the injury, when compared to standard neurological clinical testing methods.
The subjective results of the concussed participants SCAT test, which is performed immediately following the injury, and the Symptom Indicator questions which are asked each time a recording is taken, are compared to the objective results obtained from the Head Pulse measurement device. These recordings track the brains recovery in the days following the injury. The recordings are also compared to the cumulative 'normal' readings of the control group (non-concussed participants) to clearly highlight the 'abnormal' readings of concussed participants.

Timepoint [2]

Both concussed and non-concussed participants will have multiple sequential recordings taken.
Concussed participants will be measured within 60 minutes of the injury occurring, then daily for the following two weeks. In weeks 3 and 4, three recordings per week will be taken.

Non- concussed participants will be tested fortnightly for a minimum of 15 times throughout the 6 month study period.

Secondary outcome [1]

The study will determine the impact that returning to normal physical activity
has on the participants brain's recovery from concussion. Fitbit GPS trackers will be assigned to concussed participants to measure how their Head Pulse recordings are affected by physical activity in the recovery process, which will then be compared to participants who remain sedentary through the recovery period.

Timepoint [1]

These recordings will occur through the 30 day post concussion recovery period.

Eligibility

Key inclusion criteria

Male and female Australian footballers competing in the Adelaide Footy League.
Aged between 18 and 35 years
Control participants cannot have recorded a concussion for the previous 12 months.
All participants must have signed an informed consent form

Minimum age

18 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Must be competitors in the Adelaide Footy League

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is a feasibility study to see how well we can record the head pulse from healthy participants and participants with concussion. If good quality data is obtained, the aim is to develop a model of head movement in the setting of concussion and recovery from concussion. Head pulse waveforms in each recording session will be normalized to the cardiac cycle to determine its characteristics in the space and frequency domains. Using this information , we will begin to develop an algorithm to categorize known, externally measured variables such as imaging characteristics or brain function characteristics with regard to how these variables align with head movement waveforms. We will compare waveforms obtained in participants with concussion to waveforms obtained in healthy controls.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2022

Actual

21/03/2022

Date of last participant enrolment

Anticipated

31/08/2022

Actual

27/08/2022

Date of last data collection

Anticipated

30/09/2022

Actual

27/09/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sport and Real Knowledge P/L

Address [1]

506 Greenhill Road,
Hazelwood Park, SA, 5066

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Sport and Real Knowledge P/L

Address

506 Greenhill Road,
Hazelwood Park, SA, 5066

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

Bellberry Office
123 Glen Osmond Road
Eastwood, SA, 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/11/2021

Approval date [1]

11/03/2022

Ethics approval number [1]

Summary

Brief summary

We hypothesize that concussion will alter the amplitude and frequency characteristics of measured head movements induced by cerebral blood flow during a cardiac cycle, and that it will be feasible to measure these changes using a non invasive, external device at various timepoints after concussion. 
We will evaluate the feasibility of using a novel, external cranial accelerometry device for individuals with concussion. Specifically we will determine the practicality of obtaining head pulse recordings at various time points after injury and during recovery from concussion.

Trial website

www.sparktrials.com.au

Trial related presentations / publications

N/A

Public notes

Contacts

Principal investigator

Name

Prof Professor Kevin Norton

Address

Adelaide Fitness Solutions
3 Giles Avenue,
Glenelg South, SA, 5045

Country

Australia

Phone

+61 0417817026

Fax

kevin.norton@unisa.edu.sa

Contact person for public queries

Name

Keith Thomas

Address

Sport and Real Knowledge P/L
506 Greenhill Road,
Hazelwood Park, SA 5066

Country

Australia

Phone

+61 0417771588

Fax

k.thomas@sparktrials.com.au

Contact person for scientific queries

Name

Professor Kevin Norton

Address

Adelaide Fitness Solutions
3 Giles Avenue,
Glenelg South, SA, 5045

Country

Australia

Phone

+61 0417817026

Fax

kevin.norton@unisa.edu.sa

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We consider that the secure, confidential treatment of all data collected during this trial is critically important to ensure that the information gathered cannot be used to assist in the diagnosis of concussion in participants. This must remain the exclusive domain of qualified medical staff.

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
14011	Informed consent form	k.thomas@sparktrials.com.au	The informed consent form is descriptive in nature... [More Details]
14015	Study protocol	k.thomas@sparktrials.com.au
14016	Ethical approval	k.thomas@sparktrials.com.au

Results publications and other study-related documents

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