Status:
RECRUITING
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Lead Sponsor:
University of Alberta
Conditions:
Trigeminal Neuralgia (TN)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the feasibility and potential benefit of Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early treatment option for trigeminal neuralgia (TN)....
Detailed Description
Background Trigeminal neuralgia (TN) is a chronic, often debilitating, neuropathic facial pain condition with an approximate global incidence of 12 cases per 100,000 and a female predominance of 3:2, ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Clinical diagnosis of classical or idiopathic TN, based on clinical history and MRI scan
- Onset of pain within 2 years prior to enrolment
- Not deemed medically refractory (defined as uncontrolled pain despite ≥2 medication trials, not requiring escalating dose)
- If currently on medication, on stable dose x at least 3 months
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06949436
Start Date
July 30 2025
End Date
May 1 2032
Last Update
November 18 2025
Active Locations (2)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7