Radiosurgery for Trigeminal Neuralgia

Overseen By Laronica K. Conway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prior brain radiosurgery, Multiple sclerosis, Skull tumor, others

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

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is radiosurgery for trigeminal neuralgia safe for humans?

Radiosurgery for trigeminal neuralgia is generally considered safe, but some patients may experience sensory disturbances after treatment. Studies have shown that different techniques and equipment can affect the dose distribution, which is important for minimizing complications. ^{1 2 3 4 5}

How is the Unframed Virtual Cone treatment different from other treatments for trigeminal neuralgia?

The Unframed Virtual Cone treatment for trigeminal neuralgia is unique because it uses a frameless, non-invasive approach to target a larger segment of the trigeminal nerve with high precision, unlike traditional methods that may require a fixed frame or less precise targeting. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Unframed Virtual Cone for trigeminal neuralgia?

Research on similar treatments like linear accelerator radiosurgery and Cyberknife radiosurgery shows they can effectively reduce pain and improve quality of life for people with trigeminal neuralgia, suggesting that Unframed Virtual Cone might also be effective. ^{2 6 11 12 13}

Who Is on the Research Team?

John B. Fiveash

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are expected to live for more than 12 months.

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

You had a brain MRI in the last 12 months to make sure there are no other reasons for your facial pain.

Exclusion Criteria

I have unusual facial pain or headache conditions.

Patients with medical contra-indications to MR imaging (e.g. pacemaker)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 80 Gy Virtual Cone Radiosurgery unframed (face mask)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain relief and quality of life

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Unframed Virtual Cone

Trial Overview 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.

How Is the Trial Designed?

Group I: 80 Gy Radiation & Unframed Virtual Cone Experimental Treatment 2 Interventions

80 Gy Virtual Cone Radiosurgery unframed (face mask)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Cyberknife radiosurgery in treating trigeminal neuralgia. [2022]

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

Effectiveness of Gamma Knife Radiosurgery in Improving Psychophysical Performance and Patient's Quality of Life in Idiopathic Trigeminal Neuralgia. [2018]

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

Linear accelerator radiosurgery for trigeminal neuralgia. [2022]

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

Radiosurgical treatment of trigeminal neuralgia: evaluating quality of life and treatment outcomes. [2019]

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

Image-Guided Robotic Radiosurgery for Trigeminal Neuralgia. [2023]

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

Viability of the virtual cone technique using a fixed small multi-leaf collimator field for stereotactic radiosurgery of trigeminal neuralgia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Factors affecting outcome in frameless non-isocentric stereotactic radiosurgery for trigeminal neuralgia: a multicentric cohort study. [2021]

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

Comparison of trigeminal neuralgia radiosurgery plans using two film detectors for the commissioning of small photon beams. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Comparative analyses of linac and Gamma Knife radiosurgery for trigeminal neuralgia treatments. [2006]

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

Radiation induced vascular injury after stereotactic radiosurgery for trigeminal neuralgia: case report. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Cyberknife radiosurgery for trigeminal neuralgia. [2017]

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

Clinical evaluation of targeting accuracy of gamma knife radiosurgery in trigeminal neuralgia. [2022]

13. Italy pubmed.ncbi.nlm.nih.gov

The role of radiosurgery in trigeminal neuralgia. [2018]