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Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

Trigeminal Neuralgia (TN)

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).

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* 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 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

Study Location

University of Alberta Hospital
University of Alberta Hospital
Edmonton, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: NCT06949436