Trial Review

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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] 300366 0
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 315979 0
Condition category
Condition code
Stroke 315364 315364 0 0
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] 316648 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322647 0
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] 322647 0
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] 322648 0
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] 322648 0
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] 379175 0
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] 379175 0
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] 379176 0
The mean difference between brain temperature (as assessed using magnetic resonance thermometry) and body temperature (as assessed using a rectal temperature probe).
Timepoint [2] 379176 0
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
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 22270 0
New Zealand
State/province [1] 22270 0
Auckland

Funding & Sponsors
Funding source category [1] 304791 0
Other
Name [1] 304791 0
Myrtle Martin Neurology Research Fund
Country [1] 304791 0
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] 305110 0
None
Name [1] 305110 0
Address [1] 305110 0
Country [1] 305110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305205 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 305205 0
Ethics committee country [1] 305205 0
New Zealand
Date submitted for ethics approval [1] 305205 0
03/02/2020
Approval date [1] 305205 0
24/04/2020
Ethics approval number [1] 305205 0
20/NTB/31

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99602 0
Prof P. Alan Barber
Address 99602 0
University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
1142
Country 99602 0
New Zealand
Phone 99602 0
+6499236520
Fax 99602 0
Email 99602 0
[email protected]
Contact person for public queries
Name 99603 0
P. Alan Barber
Address 99603 0
University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
Country 99603 0
New Zealand
Phone 99603 0
+6499236520
Fax 99603 0
Email 99603 0
[email protected]
Contact person for scientific queries
Name 99604 0
William K Diprose
Address 99604 0
Auckland City Hospital
Department of Neurology
2 Park Road, Grafton
Auckland 1023
Country 99604 0
New Zealand
Phone 99604 0
+6493670000
Fax 99604 0
Email 99604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseActive conductive head cooling of normal and infarcted brain: A magnetic resonance spectroscopy imaging study.2022https://dx.doi.org/10.1177/0271678X221107988
N.B. These documents automatically identified may not have been verified by the study sponsor.