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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores Gamma Knife Radiosurgery to determine its effectiveness for trigeminal neuralgia (TN), a condition causing severe facial pain. Researchers aim to discover if earlier use of this treatment can offer longer-lasting pain relief and reduce reliance on high-dose medications. Participants will either continue their usual treatment or receive the Gamma Knife procedure. The trial seeks individuals who have experienced TN pain for less than two years and have tried medication without needing increased dosages. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that Gamma Knife stereotactic radiosurgery is safe for treating trigeminal neuralgia?

Research has shown that Gamma Knife radiosurgery (GK-SRS) for trigeminal neuralgia (TN) is generally well-tolerated by patients. Studies have found that it provides good pain relief for many individuals. Specifically, about 69-85% of patients experienced pain relief after one year, and 59% maintained relief after two years. However, effectiveness may decrease over time, with approximately 38-52% continuing to feel relief after five years.

Safety information indicates that GK-SRS is a safe option, as it typically does not cause serious side effects. Starting treatment with Gamma Knife earlier might lead to faster pain relief, especially for those who haven't undergone surgery before. While no major safety issues have been reported, individual experiences can vary. Participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for trigeminal neuralgia?

Gamma Knife stereotactic radiosurgery is unique because it offers a non-invasive alternative for treating trigeminal neuralgia. Unlike traditional surgical options that might involve incisions or altering nerve pathways, this technique uses highly focused radiation to target and disrupt the nerve causing the pain. Researchers are excited because this method minimizes the risks associated with open surgery and can be precisely controlled, potentially resulting in fewer side effects and a quicker recovery.

What evidence suggests that Gamma Knife stereotactic radiosurgery is effective for trigeminal neuralgia?

Studies have shown that Gamma Knife radiosurgery can effectively treat trigeminal neuralgia, a condition causing severe facial pain. In one study, 86% of patients initially reported improvement, and 77% experienced significant pain relief over time. Another study found that 66.6% to 100% of patients became pain-free shortly after treatment. Overall, most patients reported good to excellent results, even when other treatments failed. In this trial, participants will either receive Gamma Knife radiosurgery or continue their medical management as determined by their treating physician. This suggests that Gamma Knife radiosurgery can provide substantial pain relief for many with this condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4052001/

Trigeminal neuralgia treatment outcomes following Gamma ... The success rate of GKRS for treatment of medically intractable TN declines over time with 32 % reporting ideal outcome and 63 % reporting good outcome.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875022018162

Long-Term Results of Gamma Knife Radiosurgery for ... In Gamma Knife radiosurgery for trigeminal neuralgia, the short-term treatment outcomes have demonstrated pain-free status in 66.6%–100% of the cases (mean, ...

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/774556

Gamma Knife Radiosurgery for Trigeminal Neuralgia Initial improvement in trigeminal neuralgia was noted in 91 patients (86%). At last follow-up, significant pain relief was noted by 77% of patients (good plus ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00219-2/fulltext

Biologically effective dose and dose-rate in gamma knife ... In this study, we performed a meta-analysis to investigate the impact of dose-rate and BED in trigeminal neuralgia pain response to GKRS. We ...

5. southsoundgammaknife.com southsoundgammaknife.com/wp-content/uploads/2020/10/SSGK_Trigem_Abstract2018.pdf

A Private Institution ... Gamma Knife stereotactic radiosurgery is an effective treatment of Trigeminal Neuralgia. Patient outcomes are comparable to other published reports. No ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875017317412

Outcomes of Two-Isocenter Gamma Knife Radiosurgery for ... Kaplan-Meier analysis showed that the patients with a shorter history of TN and the patients without preoperative surgery achieved earlier initial pain relief.

7. eymj.org eymj.org/DOIx.php?id=10.3349/ymj.2020.61.2.111

Gamma Knife radiosurgery on the trigeminal root entry ... Pain control was achieved in 69–85% of cases at 1 year, 59% at 2 years, and 38–52% at 5 years.35, 36 Regarding long-term results, rates of pain ...

8. e-neurofunction.org e-neurofunction.org/upload/pdf/nf-2024-00115.pdf

The role of Gamma Knife radiosurgery in trigeminal ... A retrospective study of 121 patients who under- went GKRS found that early GKRS within 3 years from symptom onset resulted in faster pain ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3202097/

Clinical Outcomes of Gamma Knife Radiosurgery in the ... Following the initial GK procedure to the tumor, 12 patients (57%) had an excellent response and 1 patient (5%) had a good response. A total of eight patients ...