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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for trigeminal neuralgia, a condition causing severe facial pain. The focus is on Unframed Virtual Cone radiosurgery, a non-invasive treatment using targeted radiation without a head frame, aiming to increase patient comfort. The researchers aim to determine if this method is effective at one hospital before expanding to other locations. Candidates include those with trigeminal neuralgia not controlled by medication and a recent MRI showing no other pain causes. As an unphased trial, this study offers patients access to innovative treatments that could enhance their quality of life.

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 prior data suggests that the Unframed Virtual Cone is safe for trigeminal neuralgia radiosurgery?

Research has shown that the Unframed Virtual Cone treatment for trigeminal neuralgia is generally easy for patients to handle. In one study, all patients reported satisfaction with the procedure and would recommend it to others, indicating good results without major problems.

Another study examined the safety of frameless stereotactic radiosurgery, a precise type of radiation therapy, for people with trigeminal neuralgia. The results indicated that the treatment is safe, with no serious side effects for patients.

Overall, this non-invasive treatment likely carries a lower risk of complications. While these findings are encouraging, discussing any concerns with a healthcare provider before joining a trial is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unframed Virtual Cone radiosurgery for trigeminal neuralgia because it offers a unique, targeted approach to pain relief. Unlike traditional treatments like medication or invasive surgery, this method uses precise 80 Gy radiation delivered with a face mask, eliminating the need for a rigid frame. This non-invasive technique aims to reduce discomfort and improve patient experience while maintaining accuracy, potentially leading to faster recovery and fewer side effects.

What evidence suggests that this Unframed Virtual Cone radiosurgery is effective for trigeminal neuralgia?

Research has shown that Unframed Virtual Cone radiosurgery, which participants in this trial will receive, can greatly reduce pain for people with trigeminal neuralgia. Studies have found that about 80% of patients experience pain relief within six months after the treatment. One study reported that all patients were satisfied with the procedure after three months and would recommend it to others. This treatment is unique because it uses a frameless and non-invasive method, effectively targeting a larger area. Overall, evidence suggests that this technique is promising for managing trigeminal neuralgia pain. ^{1 2 4 5 6}

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. sciencedirect.com sciencedirect.com/science/article/pii/S036030162201152X

Patient Reported Outcomes after Frameless Virtual Cone ... Frameless virtual cone stereotactic radiosurgery for trigeminal neuralgia appears to provide similar outcomes in pain relief (∼80% at 6 months)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6127970/

The virtual cone: A novel technique to generate spherical ... The purpose of the trial is to determine the feasibility of frameless trigeminal neuralgia radiation surgery using the virtual cone and to measure pain relief ...

3. researchgate.net researchgate.net/publication/364685620_Patient_Reported_Outcomes_after_Frameless_Virtual_Cone_Radiosurgery_for_Trigeminal_Neuralgia

Patient Reported Outcomes after Frameless Virtual Cone ... At 3 months 27/27 (100%) of patients were satisfied with the procedure and would recommend it to family member or friend. Conclusion From our ...

4. withpower.com withpower.com/trial/phase-neuralgia-10-2015-7591c

Radiosurgery for Trigeminal Neuralgia · Info for Participants 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 ...

5. thejns.org thejns.org/view/journals/j-neurosurg/137/1/article-p217.xml

Linear accelerator–based radiosurgery for trigeminal neuralgia The authors provide data on the long-term outcomes of linear accelerator–based radiosurgery for trigeminal neuralgia and demonstrate that ...

6. redjournal.org redjournal.org/article/S0360-3016(25)03662-4/fulltext

Radiosurgery Outcomes in Pure Venous Conflict ... This study evaluates the efficacy and safety of frameless stereotactic radiosurgery (SRS) in patients with TGN secondary to isolated venous neurovascular ...