AURORA (NEURON GUARD Srl, Modena, Italy) is an innovative system for the management and selective control of the temperature of the brain area (cTTM ®), ensuring brain protection. Thanks to a collar equipped with active elements, a high and efficient heat exchange with the large arterial vessels of the neck is ensured, reducing the temperature of the brain and, consequently, the total body temperature.
The selective cooling system allows you to avoid the side effects of conventional cooling methods, optimizing the therapeutic strategy in managing the temperature of both the brain area and the total body.
In a first feasibility study based on an animal model, the effectiveness of the AURORA device equipped with a cooling collar was demonstrated, capable of creating and maintaining areas at different and separate temperatures (cerebral and body) to limit the adverse effects of “total body” cooling, while optimizing the beneficial therapeutic effect over time.
The SELETHERM study assessed the safety of delivering selective brain temperature management in humans with a cervical external cooling device (medical device AURORA).
Design: open-label, randomized and case-controlled
Participants: 10 adult patients with traumatic brain injury and refractory intracranial hypertension.
Intervention: Conventional therapy for the reduction of intracranial pressure, and:
- cTTM ® (AURORA) (study group, n = 5)
- TTM (Arctic Sun 5000) (control group, n = 5)
Primary endpoint: maintenance of intracranial pressure below 20 mmHg. The brain-to-core temperature differential was measured as an indicator of feasibility
Results:
- Excellent control of intracranial pressure in all patients, with average values less than 16 mmHg.
- Maintenance of brain temperature at optimal values 36.2°C [35.1 – 37.0]
- Maintenance of body temperature at optimal values 37.0°C
- No adverse events were reported