Tests a cooling device to control body temperature after ischemic stroke
Tests a temperature-control device in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Targeted Temperature Management in Acute Ischemic Stroke
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of BolognaBologna, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Usl di Bologna
- Trial code
- NCT07096687
- Record updated
- 17 September 2025
- Original description
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.Read full original descriptionShow less
Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot 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.
Inclusion: 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: Stroke involving multiple vascular territories; Presence of intracerebral hemorrhage; Moderate-to-severe or severe pre-stroke disability defined as mRS >3; Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI; Pregnancy.