40 Participants Needed

Radiosurgery for Trigeminal Neuralgia

KK
LK
Overseen ByLaronica K. Conway
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.46789

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.510111213

Research Team

Dr. John Fiveash, MD - Birmingham, AL ...

John B. Fiveash

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.
I am 18 years old or older.
See 3 more

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.
See 1 more

Timeline

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)

Treatment Details

Interventions

  • Unframed Virtual Cone
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 80 Gy Radiation & Unframed Virtual ConeExperimental Treatment2 Interventions
80 Gy Virtual Cone Radiosurgery unframed (face mask)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

References

Cyberknife radiosurgery in treating trigeminal neuralgia. [2022]
Effectiveness of Gamma Knife Radiosurgery in Improving Psychophysical Performance and Patient's Quality of Life in Idiopathic Trigeminal Neuralgia. [2018]
Linear accelerator radiosurgery for trigeminal neuralgia. [2022]
Radiosurgical treatment of trigeminal neuralgia: evaluating quality of life and treatment outcomes. [2019]
Image-Guided Robotic Radiosurgery for Trigeminal Neuralgia. [2023]
Viability of the virtual cone technique using a fixed small multi-leaf collimator field for stereotactic radiosurgery of trigeminal neuralgia. [2023]
Factors affecting outcome in frameless non-isocentric stereotactic radiosurgery for trigeminal neuralgia: a multicentric cohort study. [2021]
Comparison of trigeminal neuralgia radiosurgery plans using two film detectors for the commissioning of small photon beams. [2021]
Comparative analyses of linac and Gamma Knife radiosurgery for trigeminal neuralgia treatments. [2006]
10.United Statespubmed.ncbi.nlm.nih.gov
Radiation induced vascular injury after stereotactic radiosurgery for trigeminal neuralgia: case report. [2022]
Cyberknife radiosurgery for trigeminal neuralgia. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical evaluation of targeting accuracy of gamma knife radiosurgery in trigeminal neuralgia. [2022]
The role of radiosurgery in trigeminal neuralgia. [2018]