Gamma Knife Radiosurgery for Trigeminal Neuralgia

(URGEnt-TN Trial)

Overseen By Amanda R Lussoso, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Secondary TN, Bilateral TN, Prior cranial radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be on a stable dose for at least 3 months before joining. This suggests you may continue your current medications if they meet this condition.

What data supports the effectiveness of the treatment Gamma Knife Stereotactic Radiosurgery for trigeminal neuralgia?

Research shows that Gamma Knife radiosurgery is effective for trigeminal neuralgia, with 86% of patients initially responding well, and many experiencing significant pain relief. A higher dose of treatment was linked to better outcomes, and no patients reported new sensory issues. ^{1 2 3 4 5}

Is Gamma Knife Radiosurgery safe for treating trigeminal neuralgia?

Gamma Knife Radiosurgery has been shown to be generally safe for treating trigeminal neuralgia, with studies reporting it as a safe and effective method. Some complications, like dry-eye, have been noted, but overall, it is considered a safe treatment option for this condition. ^{6 7 8 9 10}

How is Gamma Knife radiosurgery different from other treatments for trigeminal neuralgia?

Gamma Knife radiosurgery is unique because it is a non-invasive treatment that uses focused radiation beams to target and inactivate specific areas in the brain, providing pain relief for trigeminal neuralgia without the need for traditional surgery. ^{4 11 12 13 14}

Eligibility Criteria

This trial is for individuals with trigeminal neuralgia, a type of neuropathic facial pain. Participants should be candidates for an early treatment approach and willing to undergo various assessments including MRI, heart rate and blood pressure measurements, as well as answer health-related questionnaires.

Inclusion Criteria

If currently on medication, on stable dose x at least 3 months

I have been diagnosed with classical or idiopathic trigeminal neuralgia, confirmed by my clinical history and an MRI scan.

My pain started less than 2 years ago.

Exclusion Criteria

Bilateral TN

History of psychiatric diagnoses within 2 years of study participation, or uncontrolled, concurrent psychiatric illness (e.g., depression with recent suicide attempts)

I have no medical reasons preventing me from having Gamma Knife radiosurgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Gamma Knife stereotactic radiosurgery (GK-SRS) for trigeminal neuralgia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up visits at 6, 12, 24 months, and 5 years

Questionnaire and Assessment

Participants complete medical histories, neurological examinations, and various health questionnaires

15-30 minutes per session

Treatment Details

Interventions

• Gamma Knife Stereotactic Radiosurgery

Trial Overview The study tests Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early intervention for trigeminal neuralgia. It aims to determine if this early surgical approach provides longer-lasting pain relief, reduces the need for high-dose medications, and has fewer complications than other treatments.

Participant Groups

Group I: Gamma Knife stereotactic radiosurgery for TN Experimental Treatment 1 Intervention

Group II: Standard arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for trigeminal neuralgia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for trigeminal neuralgia: the initial experience of The Barrow Neurological Institute. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Outcome of radiosurgery treatment with a linear accelerator in patients with trigeminal neuralgia. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for trigeminal neuralgia: results and expectations. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Trigeminal neuralgia radiosurgery: the University of Pittsburgh experience. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Repeat gamma knife radiosurgery for trigeminal neuralgia. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for trigeminal neuralgia: the dry-eye complication. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for primary trigeminal neuralgia using the Leksell Gamma unit. [2017]

9. France pubmed.ncbi.nlm.nih.gov

[Radiosurgery in trigeminal neuralgia: long-term results and influence of operative nuances]. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Dedicated Linear Accelerator Radiosurgery for Classic Trigeminal Neuralgia: A Single-Center Experience with Long-Term Follow-Up. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery for trigeminal neuralgia: first case series from Latin America. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Linear accelerator stereotactic radiosurgery for trigeminal neuralgia. [2022]

13. India pubmed.ncbi.nlm.nih.gov

The efficacy of gamma knife radiosurgery in patients with trigeminal neuralgia: The initial experience of the Bezmialem Vakif University. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Predictive variables for the successful treatment of trigeminal neuralgia with gamma knife radiosurgery. [2012]