RECRUITINGINTERVENTIONAL

Targeted Temperature Management in Acute Ischemic Stroke

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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; - willing to sign a consent form obtained for study participation. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

Locations (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, Bologna, Italy