[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589055":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":12,"centralContacts":24,"locations":29,"responsibleParty":57,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":12,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":32,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard arm","NO_INTERVENTION","Patients allocated to the standard arm will continue their medical management per the judgment of treating physician.",null,{"label":14,"type":15,"description":12,"interventionNames":16},"Gamma Knife stereotactic radiosurgery for TN","EXPERIMENTAL",[17],"Procedure: GK SRS",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"PROCEDURE","GK SRS","Under local anaesthesia, a Leksell stereotactic head frame is fixed to the patient's head to allow for complete cranial immobilization during treatment. The retrogasserian (i.e., mid-cisternal) target will be utilized at a single 4 mm isocenter, and 40 Gy will be administered to the 50% isodose line while limiting the brainstem to 12 Gy.",[14],[25],{"name":26,"role":27,"phone":12,"phoneExt":12,"email":28},"Amanda R Lussoso, BA","CONTACT","lussoso@ualberta.ca",[30,44],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":12},"University of Alberta Hospital","RECRUITING","Edmonton","Alberta","T6G 2B7","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-113.46871,53.55014,{"lat":42,"lon":41},{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":45,"geoPoint":47,"contacts":48},{"type":39,"coordinates":46},[41,42],{"lat":42,"lon":41},[49,53,55],{"name":50,"role":27,"phone":51,"phoneExt":12,"email":52},"Tejas Sankar, MDCM PhD","780-407-6869","tsankar@ualberta.ca",{"name":26,"role":27,"phone":54,"phoneExt":12,"email":28},"587-532-9085",{"name":50,"role":56,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100589055","phase-2-ultra-early-gamma-knife-stereotactic-radiosurgery-for-tn-100589055",false,"NCT06949436","Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN","Ultra-early Gamma Knife Stereotactic Radiosurgery for Trigeminal Neuralgia","URGEnt-TN","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical diagnosis of classical or idiopathic TN, based on clinical history and MRI scan\n* Clinical diagnosis within 2 years prior to enrolment\n* Not deemed medically refractory (defined as adequate pain control despite ≥2 medication trials of adequate dose. Adequate pain control is defined as pain that is considered acceptably controlled by both the patient and treating neurologist, without the need for further dose escalation)\n* If currently on medication, on stable dose x at least 3 months\n\nExclusion Criteria:\n\n* Secondary TN\n* Bilateral TN\n* Any contraindications to undergoing GK-SRS\n* Any prior cranial radiation\n* Any prior surgical intervention for TN\n* History of psychiatric diagnoses within 2 years of study participation, or uncontrolled, concurrent psychiatric illness (e.g., depression with recent suicide attempts)\n* Females who are pregnant or breast-feeding","ALL","18 Years",{"count":70,"type":71},80,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","The goal of this clinical trial is to evaluate Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early treatment option for trigeminal neuralgia (TN).\n\nThe main questions it aims to answer are:\n\n1. will earlier GK-SRS provide more durable pain relief compared to later GK-SRS?\n2. will earlier GK-SRS reduce or eliminate the need for high-dose medical therapy?\n3. will earlier GK-SRS have a lower risk of serious complications compared to other first-line treatments?\n\nIf participants are assigned to GK-SRS treatment group, they will be asked to:\n\n• Undergo a preoperative MRI, measurements of heart rate and blood pressure, stereotactic head-frame placement, post-operative management and observation.\n\nBoth groups will be asked to:\n\n* Complete medical histories and neurological examinations. These are part of standard of care.\n* Participants will be asked a series of questions related to overall physical health, pain severity, and mood. Completing these questionnaires is part of the research activity. It will take approximately 15- 30 minutes to complete. These questionnaires include: The Barrow Neurological Institute Pain Intensity Score, Brief Pain Inventory-Facial (BPI-Facial), Visual Analog Scale (VAS), Medication Quantification Scale (MQS), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Short Form Health Survey.",[77],"Trigeminal Neuralgia (TN)",[79,80,81,82],"trigeminal neuralgia","Gamma Knife","stereotactic radiosurgery","surgery","2026-04-11",{"date":85,"type":86},"2026-04-15","ACTUAL",{"date":88,"type":86},"2025-07-30",{"date":90,"type":71},"2032-05-01",{"name":5,"class":6},2]