Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
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 eli
| Condition(s) | Trigeminal Neuralgia (TN) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. Th |
| Who can participate | 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 prior cranial radiation * Any prior surgical intervention for TN * History of psychiatric diagnoses within 2 years of study participation, or uncontrolled, concurr |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Alberta |
| Locations | Edmonton, Alberta, Canada; Edmonton, Alberta, Canada |
| Start date | 2025-07-30 |
| NCT ID | NCT06949436 |
| Official listing | https://clinicaltrials.gov/study/NCT06949436 |