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NOT YET RECRUITING
NCT07844096
NA

COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.

Sponsor: Christian Medical College and Hospital, Ludhiana, India

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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