NCT07096687

Targeted Temperature Management in Acute Ischemic Stroke

Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional trial is to evaluate whether the CB240\_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240\_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240\_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240\_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.

Detailed description

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Targeted Temperature Management with CB240_Aurora	The proposed experimental treatment with the CB240\_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance 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.
DEVICE	Standard of care Temperature treatment	In the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240\_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-09-01
• Completion: 2027-03-31
• First posted: 2025-07-31
• Last updated: 2025-09-17

Locations

1 site across 1 country: Italy