None listed
Conditions
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.
Interventions
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 Univ
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.
Sponsors
Professor P. Alan Barber
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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
Outcome results
None listed