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Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

NCT06949436 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Trigeminal Neuralgia (TN)

Interventions

PROCEDURE

GK SRS

Under local anaesthesia, a Leksell stereotactic head frame is fixed to the patient's head to allow for complete cranial immobilization during treatment. The retrogasserian (i.e., mid-cisternal) target will be utilized at a single 4 mm isocenter, and 40 Gy will be administered to the 50% isodose line while limiting the brainstem to 12 Gy.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2029-05-01
Completion
2032-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06949436 on ClinicalTrials.gov