What side effects are associated with this type of intervention?

Common treatments for Trigeminal Neuralgia, such as frameless Virtual Cone Radiosurgery, often result in a high rate of initial pain relief. However, side effects can include facial hypesthesia (reduced sense of touch or sensation) and paresthesia (tingling or prickling sensation). These complications are not uncommon and can affect a significant number of patients. Pain recurrences are also possible, indicating that while effective, these treatments may have notable side effects and varying long-term outcomes.

What prior FDA approvals exist?

The FDA has approved several treatments for Trigeminal Neuralgia, primarily focusing on pharmacologic options such as anticonvulsants (e.g., carbamazepine and oxcarbazepine) and surgical interventions. While specific FDA approvals for targeted radiation therapies like Frameless Virtual Cone Radiosurgery are not detailed, radiosurgery techniques such as Gamma Knife and CyberKnife have been used off-label for this condition. These methods deliver precise radiation to the trigeminal nerve, aiming to reduce pain by disrupting nerve function.

What other types of research exist?

Promising novel alternatives to Frameless Virtual Cone Radiosurgery for Trigeminal Neuralgia include: 1) High-Dose Bevacizumab, which has shown efficacy in reducing tumor growth and preserving hearing in NF2-related conditions; 2) mTORC1 inhibitors like Everolimus, which have been studied for their potential in managing tumor growth; 3) Histone deacetylase inhibitors such as AR-42, currently in phase 1 trials for NF2-associated tumors. These alternatives are being explored for their potential benefits in managing symptoms and improving quality of life for patients.

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Radiation Therapy

Radiosurgery for Trigeminal Neuralgia

N/A

Waitlist Available

Led By John Fiveash, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an ECOG status of 0, 1, or 2

Patients must be at least 18 years of age

Must not have

Patients with atypical trigeminal neuralgia or headache pain syndromes

Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of non-invasive surgery that uses precise radiation to treat severe facial pain. It targets patients with trigeminal neuralgia who may not respond to other treatments. The goal is to see if this method can effectively reduce or stop their pain.

Who is the study for?

This trial is for adults with trigeminal neuralgia, a type of facial pain, that's not improved with medication. They should be in stable health (ECOG 0-2), have more than a year to live, and an MRI confirming their pain isn't caused by other issues. It's not for those who've had brain radiation before or have certain conditions like multiple sclerosis.

What is being tested?

The study tests a frameless radiosurgery technique called Virtual Cone on people with trigeminal neuralgia. Participants will receive an 80 Gy dose of radiation aimed at reducing facial pain without the need for physical head frames used in traditional treatments.

What are the potential side effects?

Potential side effects may include skin redness, swelling around the treatment area, fatigue, headaches, and temporary worsening of facial pain. Long-term risks might involve nerve damage leading to numbness or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My facial pain is severe and not improved with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unusual facial pain or headache conditions.

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I have had radiation therapy to my brain or the pons area before.

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I have pain due to multiple sclerosis or a skull base tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.

Secondary study objectives

Mean of Quality of Life Scores as measured by SF-36 Questionnaire

Number of Participants with treatment-related adverse events

Patient Satisfaction Scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 80 Gy Radiation & Unframed Virtual ConeExperimental Treatment2 Interventions

80 Gy Virtual Cone Radiosurgery unframed (face mask)

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Trigeminal Neuralgia include pharmacologic agents, neuromodulation techniques, and targeted radiation therapies. Pharmacologic treatments, such as anticonvulsants (e.g., carbamazepine), work by stabilizing nerve membranes and reducing abnormal electrical activity in the trigeminal nerve. Neuromodulation techniques, like transcranial magnetic stimulation (TMS), modulate neural activity to reduce pain perception. Targeted radiation therapies, such as Frameless Virtual Cone Radiosurgery, deliver precise radiation to the trigeminal nerve to disrupt pain signals without invasive surgery. These mechanisms are crucial for Trigeminal Neuralgia patients as they offer pain relief by directly addressing the abnormal nerve activity responsible for the severe facial pain characteristic of the condition.

Stereotactic radiosurgery of essential trigeminal neuralgia using Leksell Gamma Knife model C with automatic positioning system: technical nuances and evaluation of outcome in 130 patients with at least 2 years follow-up after treatment.