Targeted temperature management for acute ischemic stroke

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

This trial tests if the CB240_Aurora device can keep temperature normal and improve recovery in adults with acute ischemic stroke due to middle cerebral artery occlusion within 48 hours.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Usl di Bologna (Government)
• Locations: 1 site (Bologna, Bologna)
• Trial ID: NCT07096687 on ClinicalTrials.gov

What this trial studies

This interventional trial compares active targeted temperature management using the CB240_Aurora device to a control arm in which the device only monitors temperature in adults with anterior circulation ischemic stroke. The CB240_Aurora targets cerebral temperature via vascular heat exchange in the neck and is worn continuously for 72 hours in the Stroke Unit. Outcomes include maintenance of normothermia and clinical and radiological measures recorded at 72 hours, 7 days, and 3 months. Enrollment requires imaging-confirmed MCA occlusion and NIHSS criteria, with exclusions for hemorrhage, multiple-territory stroke, pregnancy, significant pre-stroke disability, and MRI contraindications.

Who should consider this trial

Good fit: Adults (≥18) with a first anterior circulation ischemic stroke due to MCA occlusion (M1–M3), NIHSS 6–25, symptom onset within 48 hours, axillary temperature 36–<37°C, and able to provide informed consent are ideal candidates.

Not a fit: Patients with intracerebral hemorrhage, strokes involving multiple vascular territories, pregnancy, significant pre-stroke disability (mRS >3), or contraindications to MRI or implanted pacemakers are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this device could reduce secondary brain injury by preventing fever and maintaining brain temperature, potentially improving neurological recovery after acute ischemic stroke.

How similar studies have performed: Therapeutic hypothermia has proven benefit after cardiac arrest and neonatal HIE, but TTM for acute ischemic stroke has not shown clear clinical benefit to date, and neck-based cerebral cooling devices like the CB240_Aurora remain a relatively novel approach with limited clinical evidence.

Eligibility criteria

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.

Where this trial is running

Bologna, Bologna

• IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna — Bologna, Bologna, Italy (Recruiting)

Study contacts

• Principal investigator: Andrea Zini — IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
• Study coordinator: Andrea Zini

Conditions Ischemic Stroke; ischemic stroke; neuroprotection; targeted temperature management