NCT06949436 Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
| NCT ID | NCT06949436 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Trigeminal Neuralgia (TN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-07-30 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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 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
Contact & Investigator
Amanda R Lussoso, BA
✉ lussoso@ualberta.caFrequently Asked Questions
Who can join the NCT06949436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trigeminal Neuralgia (TN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06949436 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06949436 currently recruiting?
Yes, NCT06949436 is actively recruiting participants. Contact the research team at lussoso@ualberta.ca for enrollment information.
Where is the NCT06949436 trial being conducted?
This trial is being conducted at Edmonton, Canada, Edmonton, Canada.
Who is sponsoring the NCT06949436 clinical trial?
NCT06949436 is sponsored by University of Alberta. The trial plans to enroll 80 participants.