ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000751976

Ethics application status

Approved

Date submitted

5/02/2020

Date registered

21/07/2020

Date last updated

4/08/2023

Date data sharing statement initially provided

21/07/2020

Date results provided

4/08/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

The tolerability and effectiveness of head cooling in healthy volunteers and people who have recovered from stroke

Scientific title

Tolerability and efficacy of non-invasive head COOLing in normal and HypopErfused brain : A magnetic resonance stuDy (COOLHEAD-1)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1247-2545

Trial acronym

COOLHEAD-1

Linked study record

Health condition

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

Ischaemic stroke

Condition category

Condition code

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A non-invasive head cooling device* will be applied to the participants' head and neck for up to two hours on two separate study visits.

The first study visit will occur at Auckland City Hospital, and will assess the tolerability of the cooling device. A Numerical Pain Rating Scale will be used to assess discomfort every 15 minutes. Non-invasive blood pressure and axillary or oral temperatures will be measured every 10 and 15 minutes respectively.

The second study visit will occur at the University of Auckland (Centre for Advanced MRI), and will assess the efficacy of the cooling device at reducing brain temperature. Magnetic resonance thermometry will be performed at baseline, and every 30 minutes for up to 120 minutes to measure brain temperature.

The cooling device will be administered by a medical officer with a background in internal medicine/neurology or anaesthesia.

*The non-invasive head cooling device is a thermoregulatory system that automatically reduces and maintains participant temperature. It is comprised of a flexible cap and collar that delivers temperature-controlled coolant ranging between 10°C and 15°C to a patient-contacting cooling pad, resulting in heat exchange between the coolant and the participant.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The proportion of participants who are able to tolerate non-invasive head cooling, as assessed by a study-specific questionnaire. The Numerical Pain Rating Scale will range from 0 being "no pain/discomfort" to 10 being "intolerable/need to remove the device because of discomfort."

Timepoint [1]

60 minutes following administration of the head cooling device. The Numerical Pain Rating Scale will be administered every 15 minutes during the first study visit.

Primary outcome [2]

The mean difference in baseline and post-head cooling brain temperatures (in regions of normal and/or hypoperfused brain as assessed using magnetic resonance thermometry).

Timepoint [2]

60 minutes following administration of the head cooling device. Magnetic resonance thermometry measurements will be performed at baseline, 30 minutes, 60 minutes, 90 minutes and 120 minutes during the second study visit.

Secondary outcome [1]

Timepoint [1]

120 minutes following administration of the head cooling device. The Numerical Pain Rating Scale will be administered every 15 minutes during the first study visit.

Secondary outcome [2]

The mean difference between brain temperature (as assessed using magnetic resonance thermometry) and body temperature (as assessed using a rectal temperature probe).

Timepoint [2]

60 minutes following administration of the head cooling device. Magnetic resonance thermometry and rectal temperature measurements will be performed during the second study visit.

Eligibility

Key inclusion criteria

Six participants will be healthy adults who are able to provide informed consent.

Six participants will be adults who are at least three months post-stroke with a modified Rankin Scale score of <3 and are able to provide informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. History of uncontrolled hypertension or unstable cardiovascular disease
2. Known contraindications to hypothermia, such as known haematologic dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans
3. Skin lesions not allowing secure application of the non-invasive head cooling device
4. Contraindications to having an MRI scan

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)

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

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2020

Actual

9/11/2020

Date of last participant enrolment

Anticipated

Actual

13/05/2021

Date of last data collection

Anticipated

Actual

13/05/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Myrtle Martin Neurology Research Fund

Address [1]

Department of Neurology
Level 8, Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Professor P. Alan Barber

Address

University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Level 3, Rangitoto Room, Unisys Building
650 Great South Road
Penrose
Auckland

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

03/02/2020

Approval date [1]

24/04/2020

Ethics approval number [1]

20/NTB/31

Summary

Brief summary

Endovascular thrombectomy improves outcomes in patients with ischaemic stroke. However, thrombectomy is only performed in three centres throughout New Zealand. At Auckland Hospital, 85% of patients treated with thrombectomy require inter-hospital transfer from the Northern half of the North Island. Because inter-hospital transfer increases the time it takes to open the artery causing the stroke, patients from outside of the Auckland Hospital catchment area may have more brain damage and worse outcomes than their Auckland counterparts, despite thrombectomy.

Currently, there are no methods to slow brain damage during inter-hospital transfer. Therapeutic hypothermia holds promise as an effective neuroprotective strategy in these patients, and non-invasive head cooling is a pragmatic approach that could be initiated in the pre-hospital setting, and maintained during transfer until the completion of thrombectomy.

The overarching purpose of this study is to inform two larger studies that aim to test (1) the feasibility (COOLHEAD-2), and (2) the safety and efficacy (COOLHEAD-3), of non-invasive head cooling in ischaemic stroke patients who need inter-hospital transfer for thrombectomy.

In this study, COOLHEAD-1, we aim to test whether awake participants are able to tolerate wearing a proprietary head cooling device for up to 120 minutes. We also aim to test whether a proprietary head cooling device is capable of cooling the brains of awake participants within 60 minutes. MRI scans will be used to measure brain temperature with a technique known as magnetic resonance thermometry.  

Both healthy volunteers and volunteers who have recovered from stroke will be recruited in order to test whether head cooling will preferentially cool the area of brain affected by stroke, because it has reduced (warm) blood flow to replace the heat that is absorbed by the cooling cap.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof P. Alan Barber

Address

University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
1142

Country

New Zealand

Phone

+6499236520

Fax

a.barber@auckland.ac.nz

Contact person for public queries

Name

P. Alan Barber

Address

University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6499236520

Fax

a.barber@auckland.ac.nz

Contact person for scientific queries

Name

William K Diprose

Address

Auckland City Hospital
Department of Neurology
2 Park Road, Grafton
Auckland 1023

Country

New Zealand

Phone

+6493670000

Fax

wdiprose@adhb.govt.nz

Data sharing statement

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

No/undecided IPD sharing reason/comment

No participant permission to share data outside this study.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Active conductive head cooling of normal and infarcted brain: A magnetic resonance spectroscopy imaging study.	2022	https://dx.doi.org/10.1177/0271678X221107988

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically