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COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
Sponsor: Christian Medical College and Hospital, Ludhiana, India
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) PHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):
Official title: A Pilot Randomized Controlled Trial of Conductive COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2027-09-01
Completion Date
2031-08-30
Last Updated
2026-09-28
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (5)
Amrita Institute of Medical Sciences- Kochi
Kochi, Kerala, India
All India Institute of Medical Sciences- AIIMS
New Delhi, National Capital Territory of Delhi, India
Christian Medical College and Hospital
Ludhiana, Punjab, India
Christian Medical College and Hospital, Vellore
Vellore, Tamil Nadu, India
Indian Institute of Technology, Kharagpur-IIT
Kharagpur, West Bengal, India