02 February 2026

The world’s first study to measure the effectiveness of a pioneering medical device to treat patients with traumatic head injuries will get underway at Addenbrooke’s Hospital this month (Feb) with support from the National Institute for Health and Care Research.

The Neurosciences and Trauma Critical Care team will work with patients to trial a selective brain-cooling collar, which is applied around the neck to lower brain temperature in a targeted way, with the aim of limiting swelling and secondary neurological injury.

As a selective temperature-control device, the CB240_Aurora, is designed to minimise systemic side-effects associated with conventional whole-body cooling strategies such as body-surface or intravascular cooling devices. These systemic effects may include immune suppression and chest infections, reported to complicate recovery and offset potential benefits of therapeutic temperature control.

Twenty patients with severe traumatic brain injury are expected to be enrolled over 12 months in the SELETHERM 2 study. Half will be randomised to receive selective brain cooling with the collar for the first 72 hours, while the remainder will receive standard current therapies. This study follows on from SELETHERM 1, which demonstrated the feasibility of delivering selective brain temperature management using brain and core temperature monitoring while applying active cooling pads to the neck.

SELETHERM 2, a collaboration between the adult Intensive Care, Academic Neurosurgery, and the Brain Physics Laboratory, is led by neurosciences and trauma critical care and anaesthesia consultant, Dr Andrea Lavinio, with support from Dr Alexis Joannides, consultant neurosurgeon and co-director of the NIHR HealthTech Research Centre (HRC) for Brain Injury, and Dr Edward Needham, consultant neurologist and service lead for neuroimmunology

Dr Lavinio, who is also an affiliated assistant professor at the University of Cambridge’s Department of Medicine, said: “In traumatic brain injury, hypothermia has long been considered a potentially neuroprotective strategy, but large clinical trials have not demonstrated a consistent benefit.

“One possible explanation is that the systemic side-effects associated with whole-body cooling may outweigh any neuroprotective effects of hypothermia. Despite this, consensus recommendations continue to include strict temperature control, and in selected cases therapeutic hypothermia, for patients with elevated intracranial pressure that is refractory to first-line treatment.

“This pilot study will assess whether selective, brain-directed temperature control can be delivered while minimising systemic effects, thereby informing the design of larger clinical trials and the future development of temperature-management strategies.

“An additional and particularly important aspect of the study is the simultaneous measurement of brain temperature, obtained directly via an intracranial probe, and core thoracic temperature, measured using an oesophageal probe, to explore how each relates to secondary brain injury as assessed by biomarkers.”