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Trial registered on ANZCTR


Registration number
ACTRN12619000017123
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
9/01/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of intermittent short-term selective head-neck cooling for the management of acute concussion and post-concussion syndrome
Scientific title
The use of intermittent short-term selective head-neck cooling for the management of acute concussion and post-concussion syndrome
Secondary ID [1] 296913 0
Nil Known
Universal Trial Number (UTN)
U1111-125-8322
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concussion 310863 0
post-concussion syndrome 310864 0
Condition category
Condition code
Injuries and Accidents 309534 309534 0 0
Other injuries and accidents
Neurological 309548 309548 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selective short-term intermittent head-neck cooling

Materials
The application of a reusable gel-filled cooling head and neck headset to participants identified with a sports concussion on the sideline of the sports field. The 'Cryohelmet' is a insulated neoprene shell with drawstrings to allow for adjustment of fit to the head and neck fitted with cold packs enaced in an Ultracool fabric for moisture wicking and quick drying around the head when applied to the head and neck (http://www.cryohelmet.com/store/catalyst-cryohelmet-cold-pack-set).

Arm 1: Sideline concussion assessment and management
Procedure
At all games and different venues (home and away playing format) all players will have medical coverage from the principal researcher. Once a player is identified as having a concussive injury they will be removed from further match participation and assessed on the sideline with the King-Devick Saccadic reading test and the Sports Concussion Assessment Tool (SCAT). Following this assessment, the player will be given the neoprene headset to apply to their head and wrap around their neck for 15 minutes. Following this period, the headset will be removed and the post-concussion symptom scale (PCSS) of the SCAT will be used to record their symptoms score and severity. The player will be encouraged to rest for a further 15 minutes then reapply the neoprene headgear for a further 15 minutes. Following this 15 minute period the PCSS will again be used to assess the symptoms score and severity. The player will be provided with the neoprene headset to take home and use hourly for the next two days when awake and advised to be seen medically for a further review. The player will also be provided with written instructions on the use of the headgear, concussion advice sheets containing information about warning signs to be aware of, advice for their care-provider at home and contact details of the primary researcher.

Two days following the concussion (typically the following Monday as games played on Saturday) the player will be reassessed with the SCAT, King-Devick reading test and the Brain Gauge somatosensory tactile computer program at the rugby club rooms. The PCSS will be used to further assess the players symptoms score and severity.

In conjunction with the players primary healthcare provider, they will be monitored on a graduated return to activity process and, following medical clearance to return to play they will be reassessed with the PCSS, King-Devick and Brain Gauge before returning to full match participation.

Arm 2: The use of selective intermittent short-term head-neck cooling for people with post-concussion syndrome

Procedure
Participants presenting to a post-concussion syndrome clinic will be assessed for post-concussion symptoms severity (PCSS) and then tested with the Brain Gauge and King-Devick Eye-Tracker and balance test before beginning the use of the intermittent short-term selective head-neck cooling. Following the period of cooling, the participant will be reassessed with the PCSS, Brain Gauge and King-Devick Eye Tracker and Balance test. The participant will be provided with a neoprene headset for a week to be used hourly when awake. Participants will be provided with a daily use booklet to record their symptoms before and after the use of the cooling headgear. Upon their next clinic visit (typically seven days) this will be reviewed to assess for any reduction in symptoms.

The place this will occur is the post-concussion clinic

Principal researcher and main contact person with face-to-face interaction with all participants of Arm 1 & 2
The principal researcher has 2 PhD's (injury epidemiology and Head [2010] and head impact biomechanics and sports related concussion [2015]) and is an Emergency Department Lead Clinical Nurse specialist with over 30 yrs of experience in sports injury management and healthcare.
Intervention code [1] 313186 0
Treatment: Other
Comparator / control treatment
Comparator arm is the acute concussion group

Procedure
At all games and different venues (home and away playing format) all players will have medical coverage from the principal researcher. Once a player is identified as having a concussive injury they will be removed from further match participation and assessed on the sideline with the King-Devick Saccadic reading test and the Sports Concussion Assessment Tool (SCAT). Following this assessment, the player will be given the neoprene headset to apply to their head and wrap around their neck for 15 minutes. Following this period, the headset will be removed and the post-concussion symptom scale (PCSS) of the SCAT will be used to record their symptoms score and severity. The player will be encouraged to rest for a further 15 minutes then reapply the neoprene headgear for a further 15 minutes. Following this 15 minute period the PCSS will again be used to assess the symptoms score and severity. The player will be provided with the neoprene headset to take home and use hourly for the next two days when awake and advised to be seen medically for a further review. The player will also be provided with written instructions on the use of the headgear, concussion advice sheets containing information about warning signs to be aware of, advice for their care-provider at home and contact details of the primary researcher.

Two days following the concussion (typically the following Monday as games played on Saturday) the player will be reassessed with the SCAT, King-Devick reading test and the Brain Gauge somatosensory tactile computer program at the rugby club rooms. The PCSS will be used to further assess the players symptoms score and severity.
Control group
Active

Outcomes
Primary outcome [1] 308486 0
Arm 1: Sideline concussion assessment and management
.
Changes in proportion of participants with a reduction in the number of symptoms following use of the intermittent short-term selective head-neck cooling and as reported by the participant with the PCSS of the SCAT
Timepoint [1] 308486 0
Arm 1: within seven (7) days post concussion injury
Primary outcome [2] 318498 0
Arm 2: Post concussion syndrome participants

proportion of participants with a reduction in the number of symptoms as recorded by the participants on the PCSS of the SCAT
Timepoint [2] 318498 0
Arm 2: Within seven days of starting the intermittent short-term selective head-neck cooling
Secondary outcome [1] 365168 0
effects of concussion as recorded by the participants on the PCSS of the SCAT
Timepoint [1] 365168 0
within 21 days post commencing the intermittent short-term selective head-neck cooling

Eligibility
Key inclusion criteria
Arm 1: Member of the women’s rugby union club-based team under research where they have experienced a concussive injury

Arm 2: The participant is registered for assessment and management of post-concussion syndrome through a post-concussion service provider
Minimum age
16 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those participants that do not wish to participate AND do not sign a consent form / assent form (age 16 yrs to 18 yrs)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be entered into Microsoft Excel and analysed with SPSS (IBM Corp, Released 2017. IBM SPSS Statistics for Windows, Version 25.0 Armonk, NY: IBM Corp). All data will be assessed for normality prior to analysis and reporting will be either mean (±SD) [Parametric data] or median [IQR] [Non-parametric data].

King-Devick Tests: Differences in K-D scores from pre-competition / baseline establishment and post-intervention scores will be calculated and compared utilising a Wilcoxon signed-rank test. The sensitivity and specificity of the K-D test will be calculated using a 2-by-2 contingency table with 95% CI with a Cohen kappa with 95% CI to assess for inter-rater concordance. Test-retest reliability of the K-D will be estimated utilising the intra-class correlation coefficient (ICC) with 95% CI to examine between baseline test scores and the post-intervention scores.

Sports Concussion Assessment Tool v5 (SCAT5): Differences in SCAT scores from pre-competition / baseline establishment baseline and post-intervention scores will be calculated and compared utilising a Friedman repeated measures ANOVA on ranks. If any significant differences are observed, a post-hoc analysis will undertaken by a Wilcoxon signed-rank test.

Brain Gauge: The data will be analysed by each of the cortical metrics reported using a one-way analysis of variance (ANOVA). If any significant differences are observed, a post-hoc analysis will be undertaken by a paired t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21138 0
New Zealand
State/province [1] 21138 0
Lower Hutt

Funding & Sponsors
Funding source category [1] 301483 0
University
Name [1] 301483 0
Auckland University of Technology
Address [1] 301483 0
Sport Performance Research Institute New Zealand at AUT-Millennium
Auckland University of Technology
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country [1] 301483 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Sport Performance Research Institute New Zealand at AUT-Millennium
Auckland University of Technology
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301177 0
Commercial sector/Industry
Name [1] 301177 0
TBI Physiotherapy
Address [1] 301177 0
21-23 Andrews Avenue
Lower Hutt 5010
New Zealand
Country [1] 301177 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302228 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 302228 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302228 0
New Zealand
Date submitted for ethics approval [1] 302228 0
14/01/2019
Approval date [1] 302228 0
04/03/2019
Ethics approval number [1] 302228 0
19/NTA/3

Summary
Brief summary
The aim of this research is to identify if intermittent short-term selective head-neck cooling of the head can assist with alleviating the number, severity and frequency of symptoms that occur with acute concussion, and in post-concussion syndrome and assist in the recovery of the concussed individual. To achieve this, an intermittent short-term selective head-neck cooling device (Cryohelmet) will be utilised for periods following: (a) A sport-concussion occurring during match and training activities as part of the acute post injury care; and (b) During the management of people with post-concussion syndrome as part of the treatment modality. The effects of the intermittent short-term selective head-neck cooling of the head will be monitored by (1) a self-reported ‘Use Diary’ and (2) By a variety of validated concussion assessment tools
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89510 0
Dr Doug King
Address 89510 0
Sport Performance Research Institute New Zealand at AUT-Millennium
Auckland University of Technology
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country 89510 0
New Zealand
Phone 89510 0
+64 22 034 1580
Fax 89510 0
Email 89510 0
doug.king35@gmail.com
Contact person for public queries
Name 89511 0
Dr Doug King
Address 89511 0
Sport Performance Research Institute New Zealand at AUT-Millennium
Auckland University of Technology
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country 89511 0
New Zealand
Phone 89511 0
+64 22 034 1580
Fax 89511 0
Email 89511 0
doug.king35@gmail.com
Contact person for scientific queries
Name 89512 0
Dr Doug King
Address 89512 0
Sport Performance Research Institute New Zealand at AUT-Millennium
Auckland University of Technology
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country 89512 0
New Zealand
Phone 89512 0
+64 22 034 1580
Fax 89512 0
Email 89512 0
doug.king35@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The results of the research will be collectively reported in the current process but this will be reviewed as the research progresses. If individual participant data is required or identified to be reported this will be made available
What supporting documents are/will be available?
Study protocol
Informed consent form
Other
'Other' documents specified
Head cooling sideline information form
Cooling PCS information sheet
How or where can supporting documents be obtained?
Type [1] 860 0
Study protocol
Citation [1] 860 0
Link [1] 860 0
Email [1] 860 0
Other [1] 860 0
Research Protocol for head cooling
Type [2] 861 0
Informed consent form
Citation [2] 861 0
Link [2] 861 0
Email [2] 861 0
Other [2] 861 0
Consent form for adults
Type [3] 862 0
Informed consent form
Citation [3] 862 0
Link [3] 862 0
Email [3] 862 0
Other [3] 862 0
Consent form for those aged 16-18 yrs
Type [4] 863 0
Other
Citation [4] 863 0
Link [4] 863 0
Email [4] 863 0
Other [4] 863 0
Head cooling sideline information form
Type [5] 864 0
Other
Citation [5] 864 0
Link [5] 864 0
Email [5] 864 0
Other [5] 864 0
Cooling PCS information sheet
Summary results
No Results