TARGETED TEMPERATURE MANAGEMENT IN ACUTE ISCHEMIC STROKE

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke

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

Brief Summary

The goal of this interventional trial is to learn if CB240_Aurora medical device is effective for targeted temeprature management in adult patients with acute ischemic stroke. The main questions it aims to answer are:

Does CB240_Aurora is effective to maintain normothermia in patients with acute ischemic stroke? Does the medical device improves clinical and radiological outcomes? Does the medical device is well tollereted by patients? Researchers will compare an interventional arm with CB240_Aurora mesearuning and treating body temperature to maintain normothermia, and a control arm with CB240_Aurora measuring without treating body temperature.

Participants will: wear the medical device for 72 consecutive hours in Stroke Unit. Outcomes assessment will be perfeomed at 72 hours, 7 days and 3 month.

Detailed Description

Neuroprotection is a potential therapeutic strategy to complement reperfusion in preventing the progression of cerebral ischemia in acute ischemic stroke patients. One of the most promising approaches is Targeted Temperature Management (TTM), which involves controlling body temperature to prevent fever, maintain normothermia, or induce hypothermia to reduce brain injury and improve clinical outcomes.

While hypothermia has shown clinical benefit in patients with cardiac arrest and hypoxic-ischemic encephalopathy, no significant evidence currently supports its efficacy in acute stroke.

Using TTM to maintain normothermia, could offer similar neuroprotective benefits with fewer complications.

Current guidelines for patients with intracerebral hemorrhage, subarachnoid hemorrhage, and ischemic stroke recommend maintaining body temperature between 36-37.5°C, ideally with automated control systems. In this context, Neuron Guard has developed the CB240_Aurora device, which targets cerebral temperature using the vascular anatomy of the neck to enhance heat exchange. This system has shown potential in stabilizing brain temperature while keeping body temperature near normothermia, reducing systemic side effects. Its use could be extended beyond intensive care settings to broader patient populations for managing fever episodes and enhancing neuroprotection.

The 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 inclusion in the study.

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 solely for temperature monitoring without delivering any active treatment.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_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 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 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 hours)T1; ( 72 hours)	Measure the duration (in hours) of maintained normothermia (between \>36 end \<37°C degrees Celsius) 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 Modified Rankin Scale (mRS) score, ranging from 0 to 6 with higher scores meaning worse outcome.
National Institutes of Health Stroke Scale (NIHSS)	T2 (day 7); T3 (day 90)	Clinical outcome at 7 days defined as National Institutes of Health Stroke Scale (NIHSS) score, ranging from 0 to 42 with higher scores meaning worse outcome
Change in the volume of the ischemic lesion measured by MRI	T2 (day 7)	Ischemic lesion volume will be evaluated by MR 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 along 3-months follow-up.
Number of patients requiring to stop treatment sessions	from T0 (day 0); T3 (day 90)
Qualitative assessment of device tollerability	T2 (day 7); T3 (day 90)	Ad hoc questionnaire to detect the tollerability of the device (e.g. nausea, headache, palpitations, anxiety, sweating) will be administered daily during the whole hospital stay and, after the discharge, at each outward control.

Trial Locations

Locations (1)

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