Actively Recruiting
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Led by University of Alberta · Updated on 2026-04-15
80
Participants Needed
2
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years
- Clinical diagnosis of classical or idiopathic trigeminal neuralgia based on clinical history and MRI scan
- Diagnosis made within 2 years prior to enrollment
- Not medically refractory, meaning adequate pain control despite 52 medication trials at adequate dose and no need for dose escalation
- If on medication, must be on a stable dose for at least 3 months
You will not qualify if you...
- Diagnosis of secondary trigeminal neuralgia
- Bilateral trigeminal neuralgia
- Any contraindications to undergoing Gamma Knife stereotactic radiosurgery
- Any prior cranial radiation
- Any prior surgical intervention for trigeminal neuralgia
- History of psychiatric diagnoses within 2 years or uncontrolled psychiatric illness
- Females who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
Research Team
A
Amanda R Lussoso, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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