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Enrolling by invitationOBSERVATIONAL

5-SENSE Score Validation Study

This study is about a new tool called the 5-SENSE score. It's designed for people aged 15 and over who have epilepsy that hasn't responded well to other treatments. The main goal is to see how effectively this score can predict where seizures begin in the brain. For some people, a test called Stereoelectroencephalography (SEEG) is used to pinpoint these seizure starting points. SEEG involves placing tiny wires into the brain, so it's quite a serious procedure. The 5-SENSE score uses information already gathered from routine check-ups to make this prediction. If the score can accurately tell us if SEEG will find a specific seizure spot, it could help patients avoid having this invasive diagnostic test if it's unlikely to be useful for them.

At a glance

Status
Enrolling by invitation
Sponsor
Duke University
Enrolment target
400
Start
09 Jan 2024
Estimated completion
01 Jun 2027

What is this study about?

This research study is looking into a new way to help people who have epilepsy that hasn't been brought under control with usual treatments. Sometimes, for these individuals, doctors consider a procedure called Stereoelectroencephalography (SEEG). This is a special test where small wires are carefully placed inside the brain to record brain activity and find the exact spot where seizures start. Knowing this spot can open doors for surgery that might stop the seizures.

The study is investigating a new tool called the 5-SENSE score. This score uses information from tests you would have already had, like brain scans and recordings of your brainwaves (EEG), to try and predict if SEEG would be successful in finding a clear seizure starting point. The idea is to see if this score can give doctors a better idea of whether SEEG will be helpful for a particular patient.

Ultimately, if the 5-SENSE score works well, it could mean that fewer people need to go through the SEEG procedure unnecessarily. This is important because SEEG, while very useful for some, is an invasive procedure with its own risks. The study wants to check if this score can reliably guide decisions, making the journey for people with difficult epilepsy a bit smoother and safer.

Key takeaways

  • The study tests a new scoring system called 5-SENSE.
  • It aims to predict if a brain test (SEEG) will find where seizures start.
  • Participation involves reviewing existing medical records only.
  • Could help avoid unnecessary invasive procedures for future patients.
  • For individuals aged 15 and over with hard-to-treat epilepsy.

Who may be eligible?

This study is looking for people who are at least 15 years old and have epilepsy that hasn't improved with other treatments. You would have already been discussed by a team of doctors specialising in epilepsy at your hospital, and they will have decided that surgery might be an option but it's not clear where the seizures start.

To be included, you need to have had all the usual non-invasive tests and scans. This includes detailed brain scans (MRI) and recordings of your brain activity during seizures (video-telemetry). The study needs to be able to access the original files from these tests for review.

Important note: If you haven't had these tests done at your current hospital, or if you've already had different types of electrodes (like subdural or GRID electrodes) placed on or under your brain, you wouldn't be able to join this particular study.

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. Am I at least 15 years old?
  2. Do I have epilepsy that hasn't responded to usual treatments?
  3. Has my case been discussed by an epilepsy specialist team at my hospital?
  4. Have I had detailed brain scans (MRI) and seizure recordings (video-telemetry) at my current hospital, and are the original records available?
Answer every question to see your result.

What does participation involve?

The information provided does not detail specific visits, assessments, medication, or follow-up schedules. It focuses on assessing pre-existing patient data. Therefore, your participation in this study would not typically involve extra appointments, tests, or taking new medication. It's a review of your existing medical information. The study duration for an individual patient is not specified, but it's generally about using your past medical records.

Potential risks and benefits

As this study primarily involves reviewing your existing medical records, there are generally no direct physical risks to you from participating. The potential benefit is that the results could help improve how doctors decide who needs an invasive test like SEEG in the future, making the process safer and more efficient for others. You have the right to withdraw your consent for your data to be used at any time, without affecting your medical care.

Locations (19)

  • University of Florida College of Medicine
    Verified postcode
    Gainesville, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • Duke University Health System
    Verified postcode
    Durham, United States
  • Presbyterian-Shadyside Hospital
    Verified postcode
    Pittsburgh, United States
  • Monash University
    Verified postcode
    Melbourne, Australia
  • Mater Health
    Verified postcode
    Brisbane, Australia
  • Alfred Health
    Verified postcode
    Melbourne, Australia
  • Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
    Verified postcode
    Salzburg, Austria
  • Dalhousie Universiry and Hospital
    City only
    Dalhousie, Canada
  • Wester University
    Verified postcode
    London, Canada
  • Departmet of Neurology, Masaryk University Brno
    Verified postcode
    Brno, Czechia
  • Danish Epilepsy Centre, Aarhus Universitets Hospital
    Verified postcode
    Aarhus, Denmark

Common questions

What is the 5-SENSE score?

It's a new scoring system that uses information from your existing medical tests to try and predict if a special brain test (SEEG) will help find where your seizures start.

What is SEEG?

SEEG stands for Stereoelectroencephalography. It's an invasive procedure where tiny wires are placed inside the brain to record exact brain activity and pinpoint seizure origins.

Will I have to have any extra tests if I join this study?

No, this study mainly reviews your past medical records and test results, so you shouldn't need any new or extra tests.

Why is this study important?

It could help doctors decide more accurately if an invasive and serious test like SEEG is likely to be helpful for someone, potentially saving patients from unnecessary procedures.

Who can join this study?

People aged 15 or older with difficult-to-treat epilepsy who have had specific brain scans and seizure recordings at their hospital and whose case has been discussed by an epilepsy specialist team.

How to find out more

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 "5-SENSE Score Validation Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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