RecruitingPHASE2INTERVENTIONAL

Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

This study is investigating a special type of radiation treatment called Gamma Knife stereotactic radiosurgery (GK-SRS) for people with trigeminal neuralgia (TN). We're trying to find out if having this treatment very early after diagnosis helps more than waiting. The main things we want to learn are: does early GK-SRS give longer-lasting pain relief? Does it mean people need less strong medication or none at all? And does it have a lower risk of serious complications compared to other common treatments? Participants will have some scans and checks, and everyone will complete questionnaires about their pain and health. We hope this research will help improve how TN is treated in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Alberta

Enrolment target

Start

30 Jul 2025

Estimated completion

01 May 2032

Trigeminal Neuralgia (TN)

What is this study about?

Trigeminal neuralgia (TN) is a condition that causes sudden, severe, shock-like pain in the face. This pain can be really difficult to live with and can be triggered by everyday things like chewing, talking, or even a light touch. It's caused by a problem with the trigeminal nerve in your head.

Currently, the first treatment usually involves strong medications. While these can help, they often come with side effects like dizziness, confusion, or more serious problems. Also, over time, these medications might not work as well, and many people eventually need other treatments. This study is exploring if a treatment called Gamma Knife stereotactic radiosurgery (GK-SRS) could be a better option if used very early on.

GK-SRS is a precise type of radiation therapy that targets the affected nerve without needing surgery. Researchers want to see if having this treatment soon after being diagnosed could lead to longer-lasting pain relief, reduce the need for strong pain medicines, and have fewer risks than other usual treatments. This is important because finding better ways to manage TN could really improve the quality of life for people living with this painful condition.

Key takeaways

This study explores early Gamma Knife radiosurgery for facial pain (Trigeminal Neuralgia).
It aims to see if early treatment provides longer pain relief.
Researchers will check if early treatment reduces the need for strong medications.
It also investigates if early treatment has fewer serious side effects.
Participation involves medical checks, an MRI, and questionnaires about your pain and health.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with trigeminal neuralgia (TN) within the last two years. Your doctor must have confirmed this diagnosis based on your symptoms and an MRI scan. We're looking for people whose pain is not yet controlled after trying at least two different medications at appropriate doses. If you're currently taking medication for TN, you need to have been on a stable dose for at least three months.

There are certain reasons why you might not be able to join. For example, if your TN is caused by another condition (called 'secondary TN') or if you have pain on both sides of your face ('bilateral TN'), you won't be able to take part. Also, if you've had radiation to your head or any surgery for TN before, or if you have other medical issues that make GK-SRS unsafe, you wouldn't be eligible.

Finally, if you've had certain mental health conditions in the last two years, or if you are pregnant or breastfeeding, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Trigeminal Neuralgia (TN) within the last two years?
Is your TN pain not well-controlled, even after trying at least two different medications?
Have you *not* had any previous head radiation or surgery for your TN?
Are you *not* currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll first have a full medical history taken and a check-up, which is standard care. You'll also be asked to answer some questionnaires about your general health, how much pain you're experiencing, and your mood. These questions help the researchers understand how your condition affects you and should take about 15-30 minutes to complete.

If you are placed in the GK-SRS treatment group, you will have an MRI scan before treatment, your heart rate and blood pressure will be checked, and a special frame will be gently placed on your head for the procedure. You'll then receive the GK-SRS treatment, followed by standard care and monitoring afterwards. The total duration of your involvement will depend on how long the researchers need to follow up on your pain relief and any potential side effects. There are no visits specific to this study mentioned other than the treatment itself and the questionnaires.

Potential risks and benefits

Taking part in this study could potentially offer you earlier access to a treatment that might provide more lasting pain relief and reduce your need for strong medications for trigeminal neuralgia. However, like all medical treatments, GK-SRS carries potential risks, which your medical team will discuss with you in detail. There are also potential risks related to the questionnaires, such as feeling uncomfortable discussing your pain or mood. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is Trigeminal Neuralgia (TN)?

It's a condition causing sudden, severe, shock-like pain in the face, typically from problems with the trigeminal nerve.

What is Gamma Knife Stereotactic Radiosurgery (GK-SRS)?

It's a very precise type of radiation treatment that targets the affected nerve without needing traditional surgery.

Why is 'early' treatment being studied?

Researchers want to see if treating TN very early could lead to longer pain relief, less need for strong medicines, and fewer side effects.

Will I definitely get the GK-SRS treatment?

If you are accepted into the study, you would be assigned to the GK-SRS treatment group as part of the study design.

What do the questionnaires ask about?

They ask about your overall health, how severe your pain is, and your mood. It helps researchers understand your experience.

How to find out more

Amanda R Lussoso, BA

lussoso@ualberta.ca Official trial record

Always speak to your GP or specialist before deciding to take part in a study.