Neuralgia Clinical Trials

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Ultra-early Gamma Knife Stereotactic Radiosurgery for Trigeminal Neuralgia

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 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

• 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

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