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Active not recruitingOBSERVATIONAL

Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury

This study aims to improve how we assess spinal cord injuries, especially focusing on nerves at the very bottom of the spine (sacral nerves). These nerves are really important because they give clues about how badly the spine is injured and how well someone might recover. Currently, doctors usually check these nerves by hand, which can be a bit hit-and-miss. This study is testing a new electrical method that provides clearer, measurable results. Researchers will use this new test on 250 patients shortly after their injury and then track their recovery over six months. They want to see if early results from this electrical test can accurately predict how much movement, feeling, and bowel/bladder control patients regain, helping doctors offer better treatment and more accurate recovery information.

At a glance

Status
Active not recruiting
Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Enrolment target
450
Start
18 Mar 2024
Estimated completion
31 Dec 2028

What is this study about?

When someone has a spinal cord injury, doctors need to understand how severe it is and which parts of the body are affected. An important area to check is the lower part of the spine, called the sacrum, because nerves here control things like bowel, bladder, and some leg movements. How well these nerves are working can tell doctors a lot about someone's injury and how much they might recover over time.

Currently, doctors mainly rely on a physical examination to check these nerves, which can sometimes be tricky and depends a lot on the doctor's experience. This study is looking at a new, more precise way to measure nerve activity in this area using special electrical tests. This new method aims to give clearer, measurable results, unlike the older finger-based checks. By using this electrical test, researchers hope to get a better and earlier picture of how the spinal cord injury is affecting these important nerve signals.

The main goal of this study is to see if these early electrical test results can predict a patient's recovery after six months. They want to find out if patients with better nerve signals early on tend to have a better recovery of their movement, feeling, and bowel/bladder function. This information could help doctors better understand each patient's situation, choose the best treatments, and give more accurate information about what to expect during recovery.

Key takeaways

  • New electrical test for spinal cord injury assessment.
  • Aims to predict recovery of movement, sensation, bowel, and bladder.
  • Involves tracking recovery for six months after injury.
  • Will help doctors better understand spinal cord injury severity.
  • Could lead to more personalised treatment plans in the future.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently had a spinal cord injury. This includes injuries from accidents or certain types of spinal tumours, affecting any part of the spine from the neck to the very bottom. You would need to have had surgery at the hospital participating in the study within five days of your injury, and be able to understand and give permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if your injury wasn't due to an accident or a tumour, or if you can't have the nerve test done within a week of your injury (perhaps due to being unconscious or having other brain issues). You also wouldn't be able to take part if you had other serious existing health conditions like Parkinson's disease, multiple sclerosis, or a history of severe brain injury, or if you couldn't commit to follow-up visits for six months.

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. Did you have a spinal cord injury from an accident or tumour?
  3. Did you have spinal surgery at this hospital within 5 days of your injury?
  4. Can you attend follow-up visits for 6 months?
  5. Do you have no other serious existing nerve problems?
Answer every question to see your result.

What does participation involve?

If you join this study, doctors will use a new electrical test to check the nerve signals in your lower back shortly after your spinal cord injury. You will have regular checks of your movement, feeling, and bowel/bladder function by the doctors for up to six months after your injury. These checks will include the new electrical test and standard evaluations. The study will last for six months from the time of your injury, with follow-up visits during this period. You won't be given any new medications as part of this study.

Potential risks and benefits

Taking part in this study could potentially help doctors understand and predict recovery from spinal cord injuries better in the future, which might lead to more tailored treatments. As for potential risks, the electrical test involves placing small sensors on your skin to measure nerve activity, which is generally safe and causes minimal discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Hôpital du Sacré-Coeur de Montréal
    Verified postcode
    Montreal, Canada

Common questions

What is a spinal cord injury?

A spinal cord injury happens when there is damage to the spinal cord, which is the main bundle of nerves carrying messages between your brain and the rest of your body.

What are 'sacral nerves'?

These are nerves at the very bottom of your spinal cord that control important functions like bladder and bowel control, and some sensation in that area.

What is this new 'electrical test'?

It's a way to measure how well your sacral nerves are working by using small electrical signals. It helps doctors get clearer, measurable information about nerve function.

Will this study change my current treatment?

No, this study is about assessing a new method, not about changing your primary medical treatment for the spinal cord injury.

How long will I be involved in the study?

You'll be involved for about six months after your spinal cord injury, attending follow-up visits during that time.

How to find out more

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

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