Ultra-early Gamma Knife radiosurgery for trigeminal neuralgia
Official title: Ultra-early Gamma Knife Stereotactic Radiosurgery for Trigeminal Neuralgia
Run by University of Alberta · NCT06949436 · Data updated 2026-11-12
This trial will test whether giving Gamma Knife stereotactic radiosurgery earlier for people with trigeminal neuralgia provides longer-lasting pain relief, reduces the need for high-dose medicines, and lowers the risk of serious complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | May 1, 2029 |
| Study ends | May 1, 2032 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06949436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with classical or idiopathic trigeminal neuralgia diagnosed within the last two years who are not medically refractory and who are on stable medication doses are ideal candidates.
✕Probably not a fit
Patients with secondary or bilateral TN, prior cranial radiation or TN surgery, uncontrolled psychiatric illness, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with classical or idiopathic trigeminal neuralgia diagnosed within the past two years and not yet medically refractory will be assigned to receive ultra-early Gamma Knife stereotactic radiosurgery (GK-SRS) or standard-timed care. Participants in the GK-SRS arm will undergo preoperative MRI, stereotactic head-frame placement, the radiosurgery procedure, and post-operative observation, while all participants complete medical histories, neurological exams, and regular questionnaires about pain, function, and mood. The trial measures durability of pain relief, changes in medication use, and rates of complications over follow-up. Patients with secondary or bilateral TN, prior cranial radiation or TN surgery, recent significant psychiatric illness, or who are pregnant or breastfeeding are excluded.
Why it matters
Potential benefit: If successful, ultra-early GK-SRS could provide faster and more durable pain control while reducing reliance on high-dose medications and lowering procedure-related complications.
How similar studies have gone: Gamma Knife stereotactic radiosurgery is an established effective option for trigeminal neuralgia in prior studies, but using it as an ultra-early first-line approach is relatively novel and not well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting -
University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Amanda R Lussoso, BA
- Email: lussoso@ualberta.ca
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.