NCT07844096Not yet recruiting
COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
A Pilot Randomized Controlled Trial of Conductive COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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):
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 1 Sept 2027
- Primary completion date
- 30 Aug 2031
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Diseases
- Stroke
- NCT number
- NCT07844096
What you commit to
- Study type: Interventional
- Planned participants: 55
- From 1 Sept 2027 to the primary completion date, 30 Aug 2031
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood pressure more than or equal to 185 by 110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy
Other illness
- 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
Lab values
- Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.
Other
- 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
Who the study is looking for
- PHASE l
- Healthy adult participants of any gender aged 18 years or older and able to provide
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indian Institute of Technology, Kharagpur-IIT Coordinator of this site? Confirm its status | Kharagpur | India | Unknown status |
| Amrita Institute of Medical Sciences- Kochi Coordinator of this site? Confirm its status | Kochi | India | Unknown status |
| Christian Medical College and Hospital Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| All India Institute of Medical Sciences(AIIMS) Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Christian Medical College and Hospital, Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.