Targeted Temperature Management in Acute Ischemic Stroke (TTM-STROKE)

Azienda Usl di Bologna

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Device: Standard of care Temperature treatment; Device: Targeted Temperature Management with CB240_Aurora

Study type: Interventional

Funder types: Other

Identifiers

NCT07096687

TTM-STROKE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Patients will receive targeted temperature management to maintain normothermia using the CB240\_Aurora device.

Treatment:

Device: Targeted Temperature Management with CB240_Aurora

Device: Standard of care Temperature treatment

Control Arm

Sham Comparator group

Description:

CB240\_Aurora device used exclusively in temperature monitoring and control mode according to clinical standards

Treatment:

Device: Standard of care Temperature treatment