This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke outcomes. It complements existing reperfusion therapies offering a scalable neuroprotective option which will have wider implications across diverse healthcare settings.
PHASE I: Technology Development \& Test Bench Optimization (Years 1-2) PHASE II: Validation in healthy volunteers (Year 3)
PHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):
Healthy adult participants of any gender aged 18 years or older and able to provide
informed consent.
History of uncontrolled hypertension or cardiovascular disease.
Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.
Vasospastic disorders like Raynaud or thromboangiitis obliteran.
Skin lesions not allowing secure application of the cooling system
Parallel
PEN-Cool Conductive Head-and-Neck Cooling System
DeviceA novel non-invasive active conductive combined head-and-neck cooling system designed to induce selective brain cooling while avoiding systemic hypothermia.Cooling will begin before IVT and/or EVT in the emergency department or angiography suite and continue for up to 120 minutes. The cooling system will contact the scalp and anterolateral and posterolateral neck and deliver temperatures ranging from -5°C to 0°C. Brain and core temperatures and physiological parameters will be monitored throughout the cooling period along with standard reperfusion.
Standard Reperfusion Therapy / Routine Care
Other interventionStandard of care management for acute ischemic stroke according to institutional practice, including intravenous thrombolysis, endovascular thrombectomy, or both when indicated.
Adherence to the intervention cooling system.
Phase III (Feasibility outcomes) Primary feasibility outcome defined as the proportion of participants who will be adherent to the intervention. Adherence defined as undergoing head cooling for more than equal to 60 percent of the total time from the first application of the head and neck cooling system.
Interruption of cooling system
PHASE III Secondary feasibility outcomes include interruption of cooling and the monthly enrollment rate. High recrutements are good outcome.
NIHSS
Phase III Efficacy outcomes: Early neurological improvement, defined as a 30% or greater improvement in the NIHSS score at 24 h. Lower NIHSS is good outcome
mRS
Phase III Good functional outcome at 3 months Good functional outcome, defined as an mRS of 0, 1, or 2, at 3 months assessed by telephone interview conducted by a trained researcher. Lower mRS indicates good outcome.
Safety outcome
Phase III Including bradyarrhythmia, pneumonia, shivering and cerebral vasospasm at 3 months.
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Christian Medical College and Hospital, Ludhiana, India
Lead sponsor
Indian Council of Medical Research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
