Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

NCT06949436 | Recruiting Phase 2

• 1 other identifier: SRS-0301
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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:

• 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)

Keywords

trigeminal neuralgia; Gamma Knife; stereotactic radiosurgery; surgery

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure--pain

  The primary endpoint is satisfactory pain control at 2 years after GK-SRS treatment (for Experimental Arm) or 2 years after enrolment in the Non-intervention Arm, measured using Barrow Neurological Institute Facial Pain Scale (BNI). Satisfactory pain control = BNI I, II, IIIa Barrow Neurological Institute Facial Pain Scale (BNI) I - no pain, no medication II - occasional pain, no medication required III - some pain, adequately controlled with medication IIIa - no pain, continued medication IIIb - persistent pain, controlled with medication IV - some pain, not adequately controlled with medications V - severe pain or no pain relief (lower scores indicate better outcome)

  2 years after the day of GK-SRS treatment, for participants in the Experimental Arm. 2 years after enrolment, for participants in the No-intervention Arm.

Secondary Outcomes (7)

• Secondary outcome measure - treatment-related adverse events

  At 6, 12, 24 months, and 5 years after the day of GK-SRS treatment, for participants in the Experimental Arm. At 6, 12, 24 months, and 5 years after enrolment, for participants in the No-intervention Arm

• Secondary outcome measure - medication

  Experimental Arm: Baseline visit; GK-SRS treatment visit; follow-up visits 6, 12, 24 months, and 5 years after day of GK-SRS treatment. No-intervention Arm: Baseline visit; follow-up visits 6, 12, 24 months, and 5 years after enrolment

• Secondary outcome measure - complete pain relief

  2 years after the day of GK-SRS treatment

• Secondary Outcome Measure - long term satisfactory pain relief

  5 years after day of GK-SRS treatment

• Secondary Outcome Measure - facial numbness

  At 6, 12, 24 months, and 5 years after GK-SRS treatment

Study Arms (2)

Standard arm

NO INTERVENTION

Patients allocated to the standard arm will continue their medical management per the judgment of treating physician.

Gamma Knife stereotactic radiosurgery for TN

EXPERIMENTAL

Procedure: GK SRS

Interventions

GK SRS PROCEDURE

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.

Gamma Knife stereotactic radiosurgery for TN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (1)

• Lussoso A, Patel S, Hussain W, Knash M, Bowden G, Wheatley M, Vu NK, Sankar T. Ultra-early Gamma Knife stereotactic radiosurgery for trigeminal neuralgia (URGEnt-TN): study protocol for a single-center, two-arm, parallel group design, pragmatic, noninferiority, phase II, randomized controlled trial with intention-to-treat analysis for pre-refractory GK-SRS in classical or idiopathic TN. Trials. 2025 Dec 4;27(1):15. doi: 10.1186/s13063-025-09321-8.

  PMID: 41345955 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Amanda R Lussoso, BA

CONTACT

lussoso@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will perform a single-centre, two-arm, randomized, controlled, parallel group design, pragmatic, noninferiority, phase II trial of ultra-early GK-SRS for trigeminal neuralgia in patients treated prior to developing a medically-refractory state and within 2 years of clinical diagnosis prior to enrolment. Two parallel cohorts will be studied independently of each other: patients treated with GK-SRS (surgical arm/treatment group) versus pre-refractory patients treated with ongoing best medical management (medical arm/control group). Crossover will be allowed from the medical arm to the surgical arm. An intention-to-treat analysis will be carried out.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 29, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)