[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657841":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":36,"studyPopulation":27,"armGroups":37,"interventions":50,"overallOfficials":59,"centralContacts":67,"locations":75,"responsibleParty":151,"collaborators":153,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":27,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":188,"whyStopped":27,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Christian Medical College and Hospital, Ludhiana, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Adherence to the intervention cooling system.","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.","3 months",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Interruption of cooling system","PHASE III Secondary feasibility outcomes include interruption of cooling and the monthly enrollment rate.\n\nHigh recrutements are good outcome.",{"measure":18,"description":19,"timeFrame":20},"NIHSS","Phase III Efficacy outcomes: Early neurological improvement, defined as a 30% or greater improvement in the NIHSS score at 24 h.\n\nLower NIHSS is good outcome","24 hours",{"measure":22,"description":23,"timeFrame":12},"mRS","Phase III Good functional outcome at 3 months Good functional outcome, defined as an mRS of 0, 1, or 2, at 3 months assessed by telephone interview conducted by a trained researcher. Lower mRS indicates good outcome.",{"measure":25,"description":26,"timeFrame":12},"Safety outcome","Phase III Including bradyarrhythmia, pneumonia, shivering and cerebral vasospasm at 3 months.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","(Phase I) Prospective, single-arm, non-randomized, open-label feasibility and safety study.\n\n-Assess device tolerability, safety, and cooling efficacy in healthy volunteers (n=15) under controlled conditions, with continuous monitoring of physiological parameters\n\n(Phase III) Multicentre, parallel-group, pilot randomized controlled trial with 1:1 allocation to adjunctive non-invasive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone. Centralized web-based randomization will be used.","TREATMENT",{"masking":34,"maskingDescription":35,"whoMasked":27},"NONE","This is an open-label randomized controlled trial. Participants, care providers, investigators, and outcome assessors will not be masked to treatment allocation.","PEN-Cool is a pilot, multicentre, randomized controlled trial evaluating a novel non-invasive active conductive combined head-and-neck cooling system for selective brain cooling in adults with acute ischemic stroke receiving reperfusion therapy. The study is part of a phased translational research programme involving technology development, validation in healthy volunteers, and clinical evaluation in patients with acute ischemic stroke.\n\nThe clinical trial will enroll 40 adult patients with acute ischemic stroke who are eligible for intravenous thrombolysis, endovascular thrombectomy, or both. Participants will be centrally randomized in a 1:1 ratio to either adjunctive selective brain cooling plus standard reperfusion therapy or standard reperfusion therapy alone.\n\nIn the intervention group, the conductive cooling system will be applied to the scalp and anterolateral and posterolateral neck. Cooling will begin before intravenous thrombolysis and\u002For endovascular thrombectomy in the emergency department or angiography suite and will continue for up to 120 minutes. The cooling interface will deliver temperatures ranging from -5°C to 0°C. Brain temperature will be monitored non-invasively using infrared tympanic membrane thermometry, while core body temperature will be monitored using a rectal or esophageal probe. Blood pressure, heart rate, and oxygen saturation will also be monitored.\n\nCooling will be discontinued if predefined safety or tolerability criteria are met, including intolerance, persistent cold-related shivering despite passive warming, core body temperature of 35°C or below, uncontrolled hypertension, symptomatic bradycardia or other unexpected medical events, or procedural complications.\n\nThe primary feasibility outcome is adherence to the cooling intervention, defined as receiving head cooling for at least 60% of the intended total cooling duration. Secondary feasibility outcomes include interruptions in cooling and monthly enrollment rate. Efficacy outcomes include early neurological improvement, defined as a 30% or greater improvement in NIHSS score at 24 hours, and good functional outcome, defined as a modified Rankin Scale score of 0-2 at 3 months. Safety outcomes include symptomatic bradyarrhythmia, uncontrolled hypertension, cold-related shivering, cervical or cerebral vasospasm requiring intra-arterial vasodilators, symptomatic intracranial hemorrhage, pneumonia, and mortality through 3 months. Process outcomes include time from hospital arrival to initiation of cooling and time from arrival to reperfusion therapy.\n\nThe study will assess whether selective brain cooling can be safely and feasibly integrated into acute ischemic stroke care without delaying established reperfusion workflows and will generate preliminary safety, feasibility, and efficacy data to inform a future adequately powered multicentre randomized controlled trial.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Selective Brain Cooling + Standard Reperfusion Therapy","EXPERIMENTAL","Participants will receive adjunctive non-invasive selective brain cooling using the novel active conductive combined head-and-neck cooling system in addition to standard reperfusion therapy (intravenous thrombolysis, endovascular thrombectomy, or both).",[43],"Device: PEN-Cool Conductive Head-and-Neck Cooling System",{"label":45,"type":46,"description":47,"interventionNames":48},"Standard Reperfusion Therapy \u002F Routine Care","ACTIVE_COMPARATOR","Participants will receive standard of care management for acute ischemic stroke according to institutional practice, including indicated intravenous thrombolysis and\u002For endovascular thrombectomy, without selective brain cooling.",[49],"Other: Standard Reperfusion Therapy \u002F Routine Care",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":27},"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\u002For 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.",[39],{"type":6,"name":45,"description":57,"armGroupLabels":58,"otherNames":27},"Standard of care management for acute ischemic stroke according to institutional practice, including intravenous thrombolysis, endovascular thrombectomy, or both when indicated.",[45],[60,63,65],{"name":61,"affiliation":5,"role":62},"Dr Jeyaraj D Pandian","PRINCIPAL_INVESTIGATOR",{"name":64,"affiliation":5,"role":62},"Dr ATUL PHILLIPS",{"name":66,"affiliation":5,"role":62},"Dr Ivy A Sebastian",[68,72],{"name":66,"role":69,"phone":70,"phoneExt":27,"email":71},"CONTACT","9999464986","ivy29cmc@gmail.com",{"name":73,"role":69,"phone":74,"phoneExt":27,"email":71},"Dr Jeyaraj D Pandian, MD DM","9915784750",[76,94,109,121,136],{"facility":77,"status":27,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Amrita Institute of Medical Sciences- Kochi","Kochi","Kerala","682041","India","IN",{"type":84,"coordinates":85},"Point",[86,87],76.26022,9.93988,{"lat":87,"lon":86},[90],{"name":91,"role":69,"phone":92,"phoneExt":27,"email":93},"Dr Vivek Nambiar","8921485541","dr.vivek.in@gmail.com",{"facility":95,"status":27,"city":96,"state":97,"zip":98,"country":81,"countryCode":82,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"All India Institute of Medical Sciences- AIIMS","New Delhi","National Capital Territory of Delhi","110029",{"type":84,"coordinates":100},[101,102],77.2148,28.62137,{"lat":102,"lon":101},[105],{"name":106,"role":69,"phone":107,"phoneExt":27,"email":108},"Dr Ayush Agarwal","8193900444","dr.agarwal.ayush@gmail.com",{"facility":110,"status":27,"city":111,"state":112,"zip":113,"country":81,"countryCode":82,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Christian Medical College and Hospital","Ludhiana","Punjab","141008",{"type":84,"coordinates":115},[116,117],75.85379,30.91204,{"lat":117,"lon":116},[120],{"name":66,"role":69,"phone":70,"phoneExt":27,"email":71},{"facility":122,"status":27,"city":123,"state":124,"zip":125,"country":81,"countryCode":82,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Christian Medical College and Hospital, Vellore","Vellore","Tamil Nadu","632004",{"type":84,"coordinates":127},[128,129],79.13255,12.9184,{"lat":129,"lon":128},[132],{"name":133,"role":69,"phone":134,"phoneExt":27,"email":135},"Dr Angel Miraclin","9488043281","angel_miraclin@yahoo.com",{"facility":137,"status":27,"city":138,"state":139,"zip":140,"country":81,"countryCode":82,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Indian Institute of Technology, Kharagpur-IIT","Kharagpur","West Bengal","721302",{"type":84,"coordinates":142},[143,144],87.32501,22.33971,{"lat":144,"lon":143},[147],{"name":148,"role":69,"phone":149,"phoneExt":27,"email":150},"Prof Manjunatha Mahadevappa","9475329788","mmaha2emb@gmail.com",{"type":152,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[154],{"name":155,"class":156},"Indian Council of Medical Research","OTHER_GOV","100657841","cooling-of-the-ischemic-penumbra-in-patients-with-acute-ischemic-stroke-100657841",false,"NCT07844096","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.","PEN-Cool","Inclusion Criteria:\n\nPHASE l\n\n1. Healthy adult participants of any gender aged 18 years or older and able to provide\n2. informed consent.\n\nPHASE II\n\n1\\. Adult patients of any gender, presenting with acute ischemic stroke and eligible for reperfusion therapy IVT or EVT or Both as per guidelines.\n\nExclusion Criteria:\n\nPHASE I\n\n1. History of uncontrolled hypertension or cardiovascular disease.\n2. Hematologic dyscrasias that can affect thrombosis like cryoglobulinemia or sickle cell disease or serum cold agglutinins.\n3. Vasospastic disorders like Raynaud or thromboangiitis obliteran.\n4. Skin lesions not allowing secure application of the cooling system\n\nPHASE II\n\n1. Surface Body temperature less than and equal to 35 degree Celcius at baseline\n2. Blood pressure more than or equal to 185 by 110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy\n3. 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.\n4. Skin lesions on scalp or neck preventing secure application of the cooling cap.\n5. Pre-morbid mRS more than or equal to 3\n6. Patients with known diseases or conditions resulting in an expected life expectancy of less than or equal to 3 months",true,"ALL","18 Years","99 Years",{"count":170,"type":171},55,"ESTIMATED","INTERVENTIONAL",[174],"NA","This study will develop and validate a novel, active\u002Fconductive 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.\n\nPHASE I: Technology Development \\& Test Bench Optimization (Years 1-2) PHASE II: Validation in healthy volunteers (Year 3)\n\nPHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):",[177],"Acute Ischemic Stroke",[177,179,180,163,181,182,183,184,185,186,187],"Selective brain cooling","Conductive cooling","Therapeutic hypothermia","Neuroprotection","Ischemic penumbra","Reperfusion therapy","Intravenous thrombolysis","Endovascular thrombectomy","Head and neck cooling","NOT_YET_RECRUITING","2026-09-21",{"date":191,"type":192},"2026-09-28","ACTUAL",{"date":194,"type":171},"2027-09-01",{"date":196,"type":171},"2031-08-30",{"name":5,"class":6},5]