Targeted Temperature Management in Acute Ischemic Stroke

Neuroprotection is a potential therapeutic strategy to complement reperfusion and prevent the progression of cerebral ischemia in patients with acute ischemic stroke. One of the most promising approaches is Targeted Temperature Management (TTM), which involves controlling body temperature to prevent fever, maintain normothermia, or induce hypothermia in order to reduce brain injury and improve clinical outcomes. While hypothermia has demonstrated clinical benefits in patients with cardiac arrest and hypoxic- schemic encephalopathy, no significant evidence currently supports its efficacy in acute stroke. Maintaining normothermia through TTM may offer similar neuroprotective benefits with fewer complications. Current guidelines for patients with intracerebral hemorrhage, subarachnoid hemorrhage, and ischemic stroke recommend maintaining body temperature between 36°C and 37.5°C, ideally using automated control systems.

In this context, Neuron Guard has developed the CB240_Aurora device, which targets cerebral temperature through the vascular anatomy of the neck to enhance heat exchange. This system has shown potential in stabilizing brain temperature while maintaining systemic normothermia and reducing systemic side effects. Its use could be extended beyond intensive care settings to broader patient populations, both for managing fever episodes and for enhancing neuroprotection.

The experimental treatment with the CB240_Aurora device is designed as a complementary approach to standard therapies, aiming to improve their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and <37°C at the time of study inclusion.

In the control group, patients will receive care according to the latest ischemic stroke treatment guidelines, including standard temperature management. In this group, the CB240_Aurora device will be used exclusively for temperature monitoring without providing active treatment.

Inclusion criteria

• Age >18 years;
• Both sexes;
• Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI);
• Acute ischemic stroke with symptom onset within 48 hours;
• Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3;
• NIHSS score between 6 and 25;
• First clinical stroke;
• Axillary temperature ≥36°C and <37°C;
• Informed consent obtained for study participation.

Exclusion criteria

• Stroke involving multiple vascular territories;
• Presence of intracerebral hemorrhage;
• Pregnancy;
• Moderate-to-severe or severe pre-stroke disability defined as mRS >3;
• Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.