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Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict

This study is gathering information about people who have severe face pain (like trigeminal neuralgia) or uncontrollable facial twitching (like hemifacial spasm) that doctors think might be due to a blood vessel pressing on a nerve. This pressing is called 'neurovascular conflict'. The study collects details from standard medical appointments about patients who are having a specific type of surgery called microvascular decompression (also known as a Jannetta procedure). By looking at this information from many hospitals over a long time, researchers hope to understand better how effective this surgery is, what potential side effects might occur, and what the long-term results are for patients. This will help doctors make better decisions about treatment in the future.

At a glance

Status
Not yet recruiting
Sponsor
Gerrit A Schubert
Enrolment target
5,001
Start
01 Oct 2025
Estimated completion
01 Oct 2033

What is this study about?

This study, called a 'registry', is designed to collect important health information from many different hospitals about people who have certain types of severe facial pain or muscle spasms. Specifically, it focuses on conditions like trigeminal neuralgia (which causes intense, sudden facial pain), glossopharyngeal neuralgia (pain in the throat or ear), or hemifacial spasm (involuntary twitching on one side of the face). These conditions can sometimes be caused by a blood vessel pressing against a nerve, a problem doctors call 'neurovascular conflict'.

The main goal of this registry is to track how well a particular operation, known as microvascular decompression or the 'Jannetta procedure', works for these patients. This surgery aims to relieve the pressure on the nerve. Instead of conducting a traditional trial, this study uses information that doctors already collect during routine check-ups and treatments. All this information is handled carefully to protect patient privacy.

By gathering this data in a careful and organised way from many people over a long period, researchers can learn a lot. They want to find out how effective this surgery is for different people, what kinds of side effects might happen, and how patients fare in the years following the operation. This will provide valuable evidence to help medical professionals understand the best ways to treat these challenging conditions.

Key takeaways

  • This study collects routine patient data to understand surgery outcomes.
  • It focuses on facial pain or spasms caused by a nerve being pressed.
  • The surgery being studied is called microvascular decompression (Jannetta procedure).
  • Participation involves allowing existing medical records to be used for research.
  • The goal is to improve understanding and treatment for future patients.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years or older, who doctors suspect has one of the conditions mentioned (like trigeminal neuralgia or hemifacial spasm) due to a blood vessel pressing on a nerve.

Crucially, you would also need to agree to allow researchers to use the information from your routine medical records for this study. This means signing a consent form that explains how your data will be used while keeping your privacy safe.

If you don't wish for your routine medical information to be used for this research, then you wouldn't be able to be part of this specific registry. Otherwise, if your doctors believe a nerve problem is causing your symptoms and you're willing for your routine data to be included, you might be eligible.

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.

  1. Are you 18 years old or older?
  2. Has your doctor suggested your facial pain or twitching might be due to a blood vessel pressing on a nerve?
  3. Are you considering or have you had microvascular decompression surgery?
  4. Are you happy for your routine medical information to be used for research, with your privacy protected?
Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, it's quite simple as you won't have any extra appointments or procedures. Your participation involves allowing the study team to look at the health information that your doctors already collect during your regular appointments and treatments. This includes details about your diagnosis, the microvascular decompression surgery if you have it, and how you recover or feel over time. There are no additional visits, assessments, special medications, or follow-up appointments directly required by this study. The total duration of your participation would depend on how long the registry continues to collect data on patients with your condition and treatment, but you wouldn't be asked to do anything beyond your usual care.

Potential risks and benefits

Taking part in this study primarily involves allowing your existing medical information to be used for research. There are no direct medical risks as you are not undergoing any additional tests or treatments specifically for the study. However, some people might feel uncomfortable with their health data being used for research, even with privacy safeguards. The main benefit is that by sharing your routine medical records, you're contributing to a larger pool of knowledge that will help doctors understand and potentially improve treatments for severe facial pain and spasms for future patients. You are always free to change your mind and withdraw your consent for your data to be used at any point, without affecting your medical care.

Locations (2)

  • Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University
    Verified postcode
    Aachen, Germany
  • Dept. of Neurosurgery, Cantonal Hospital Aarau
    Verified postcode
    Aarau, Switzerland

Common questions

What is 'neurovascular conflict'?

It's when a blood vessel presses against a nerve, causing symptoms like severe pain or muscle twitching.

What is the 'Jannetta procedure'?

It's a surgery called microvascular decompression, where a surgeon gently moves a blood vessel away from a nerve to relieve pressure.

Do I need to have extra appointments for this study?

No, this study only uses information already collected from your regular doctor's visits and treatments.

Is my personal information kept private?

Yes, all data is collected and used in a way that respects your privacy and follows strict rules.

Can I stop being part of the study if I change my mind?

Yes, you can withdraw your permission for your data to be used at any time, and it won't affect your medical care.

How to find out more

Stefanie Pflugi

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

Interested in taking part?

Register your interest

Share your details and the research team for "Prospective Register Study to Assess Eligibility for and Eff…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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