PEN-Cool Conductive Head-and-Neck Cooling SystemStandard Reperfusion Therapy / Routine Care
PEN-Cool Conductive Head-and-Neck Cooling System: A 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: Standard of care management for acute ischemic stroke according to institutional practice, including intravenous thrombolysis, endovascular thrombectomy, or both when indicated.
Study summary
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)
Inclusion Criteria:
PHASE l
1. Healthy adult participants of any gender aged 18 years or older and able to provide
2. informed consent.
PHASE II
1\. Adult patients of any gender, presenting with acute ischemic stroke and eligible for reperfusion therapy IVT or EVT or Both as per guidelines.
Exclusion Criteria:
PHASE I
1. History of uncontrolled hypertension or cardiovascular disease.
2. Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.
3. Vasospastic disorders like Raynaud or thromboangiitis obliteran.
4. Skin lesions not allowing secure application of the cooling system
PHASE II
1. Surface Body temperature less than and equal to 35 degree Celcius at baseline
2. Blood pressure more than or equal to 185 by 110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy
3. Known contraindications to hypothermia including hemodynamically unstable patients with new or symptomatic bradyarrhythmia known hematologic dyscrasias that affect thrombosis or vasospastic disorders such as Raynaud syndrome or thrombo angiitis obliterans.
4. Skin lesions on scalp or neck preventing secure application of the cooling cap.
5. Pre-morbid mRS more than or equal to 3
6. Patients with known diseases or conditions resulting in an expected life expectancy of less than or equal to 3 months
Primary outcome measure(s)
Adherence to the intervention cooling system. — 3 months 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.
Trial sites (5)
Facility
City
Region
Status
Amrita Institute of Medical Sciences- Kochi
Kochi
Kerala
All India Institute of Medical Sciences- AIIMS
New Delhi
National Capital Territory of Delhi
Christian Medical College and Hospital
Ludhiana
Punjab
Christian Medical College and Hospital, Vellore
Vellore
Tamil Nadu
Indian Institute of Technology, Kharagpur-IIT
Kharagpur
West Bengal
More Christian Medical College and Hospital, Ludhiana, India trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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