Targeted Temperature Management in Acute Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT07096687
• Lead Sponsor: Azienda Usl di Bologna

Brief 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.

Study Timeline

• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Status Verified: 2025-09
• Study Start: 2025-09-11
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-17
• Primary Completion: 2026-09
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of normothermia maintenance during the first 72 hours	T0 (0 hour)T1; ( 72 hours)	Measure the duration (in hours) of maintained normothermia (between \>36°C and \<37°C) through axillary temperature monitoring during the first 72 hours.

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	T2 (day 7); T3 (day 90)	Functional outcome at 3 months, defined as the Modified Rankin Scale (mRS) score ranging from 0 to 6, with higher scores indicating worse outcomes
National Institutes of Health Stroke Scale (NIHSS)	T2 (day 7); T3 (day 90)	Clinical outcome at 7 days, defined as the National Institutes of Health Stroke Scale (NIHSS) score ranging from 0 to 42, with higher scores indicating worse outcomes
Change in the volume of the ischemic lesion measured by MRI	T2 (day 7)	Ischemic lesion volume will be evaluated by MRI at day 7 from randomization (T0)
hemorrhagic transformation of the ischemic lesion at MRI	T2 (day 7)	hemorrhagic transformation of the ischemic lesion at MRI
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.	T0 (day 0); T1 (day 3); T2 (day 7); T3( day 90)	Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and during the 3-month follow-up
Number of patients requiring to stop treatment sessions	from T0 (day 0); T3 (day 90)
Qualitative assessment of device tollerability (QADT)	T2 (day 7); T3 (day 90)	An ad hoc questionnaire to assess the tolerability of the device (e.g., nausea, headache, palpitations, anxiety, sweating) will be administered daily during the entire hospital stay and, after discharge, at each outpatient follow-up visit. Responses will be categorized as: Response No (Better Outcome) and Response Yes (Worse Outcome).

Trial Locations

Locations (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna; 🇮🇹 Bologna, Bologna, Italy