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Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Alberta
NCT06949436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). The main questions it aims to answer are: 1. will earlier GK-SRS provide more durable pain relief compared to later GK-SRS? 2. will earlier GK-SRS reduce or eliminate the need for high-dose medical therapy? 3. will earlier GK-SRS have a lower risk of serious complications compared to other first-line treatments? If participants are assigned to GK-SRS treatment group, they will be asked to: • Undergo a preoperative MRI, measurements of heart rate and blood pressure, stereotactic head-frame placement, post-operative management and observation. Both groups will be asked to: * Complete medical histories and neurological examinations. These are part of standard of care. * Participants will be asked a series of questions related t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Clinical diagnosis of classical or idiopathic TN, based on clinical history and MRI scan * Clinical diagnosis within 2 years prior to enrolment * 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) * If currently on medication, on stable dose x at least 3 months Exclusion Criteria: * Secondary TN * Bilateral TN * Any contraindications to undergoing GK-SRS * Any history of head and/or neck radiation therapy * Any prior surgical intervention for TN * History of psychiatric diagnoses within 2 years of study participation, or uncontrolled, concurrent psychiatric illness (e.g., depression with recent suicide attempts) * Females who are pregnant or breast-feeding
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What it tests

  • GK SRS
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Where

2 sites
University of Alberta Hospital
Edmonton, Canada
University of Alberta Hospital
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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