Head and neck cooling to protect the brain during an acute ischemic stroke
Tests a head and neck cooling device in adults having an acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
Key facts
- Where
- Kharagpur, Kochi, Ludhiana, New Delhi, and Vellore, IndiaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07844096, who can take part
Where in India
- Indian Institute of Technology, Kharagpur-IITKharagpur, IndiaNo longer taking part
- Amrita Institute of Medical Sciences- KochiKochi, IndiaNo longer taking part
- Christian Medical College and HospitalLudhiana, IndiaNo longer taking part
- All India Institute of Medical Sciences(AIIMS)New Delhi, IndiaNo longer taking part
- Christian Medical College and Hospital, VelloreVellore, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Christian Medical College and Hospital, Ludhiana, India
- Trial code
- NCT07844096
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
A Pilot Randomized Controlled Trial of Conductive COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
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):
Inclusion: PHASE l; Healthy adult participants of any gender aged 18 years or older and able to provide; informed consent; PHASE II; Adult patients of any gender, presenting with acute ischemic stroke and eligible for reperfusion therapy IVT or EVT or Both as per guidelines.
Exclusion: Blood pressure more than or equal to 185 by 110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy; History of uncontrolled hypertension or cardiovascular disease; Vasospastic disorders like Raynaud or thromboangiitis obliteran; 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; Patients with known diseases or conditions resulting in an expected life expectancy of less than or equal to 3 months; Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins; PHASE I; Skin lesions not allowing secure application of the cooling system; PHASE II; Surface Body temperature less than and equal to 35 degree Celcius at baseline; Skin lesions on scalp or neck preventing secure application of the cooling cap; Pre-morbid mRS more than or equal to 3.