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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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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

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

Contactez l'équipe d'étude

Étude parrainée par
University of Alberta
Participants recherchés
Plus d'informations
ID de l'étude: NCT06949436