Ultra-early Gamma Knife Stereotactic Radiosurgery for Trigeminal Neuralgia: Feasibility and Potential Benefit

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
University of Alberta Hospital
RECRUITING
Edmonton
Contact Information
Primary
Amanda R Lussoso, BA
lussoso@ualberta.ca
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2032-05-01
Participants
Target number of participants: 80
Treatments
No_intervention: Standard arm
Patients allocated to the standard arm will continue their medical management per the judgment of treating physician.
Experimental: Gamma Knife stereotactic radiosurgery for TN
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov