Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

Recruiting now · Phase 2

Conditions studied: Trigeminal Neuralgia (TN)

In brief

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.

Key facts

Study ID

NCT06949436

Run by

University of Alberta

People needed

80

Starts

2025-07-30

Expected to finish

2032-05-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, concurrent psychiatric illness (e.g., depression with recent suicide attempts)
• Females who are pregnant or breast-feeding

Where it is running

• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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