Skip to content

The use of intermittent short-term selective head-neck cooling for the management of acute concussion and post-concussion syndrome

The use of intermittent short-term selective head-neck cooling for the management of acute concussion and post-concussion syndrome

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000017123
Enrollment
35
Registered
2019-01-09
Start date
2019-03-06
Completion date
2019-09-30
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.cryohelm

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.

Sponsors

Auckland University of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
No

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026