Active not recruitingOBSERVATIONAL

Incomplete Cervical SCI Without Instability

This study is for adults in the UK who have had a neck spinal cord injury that affects their movement or feeling, but where their spine is stable. It's an important study that helps doctors learn more about these types of injuries and how best to measure recovery. Participants will receive normal care decided by their surgeon, either with or without surgery. Researchers will collect information over six months, looking at things like movement, feeling, balance, and hand strength, to see which measurements are most helpful. The goal is to find better ways to understand how people recover and improve how care is given in the future.

At a glance

Status

Active not recruiting

Sponsor

AO Foundation, AO Spine

Enrolment target

Start

11 Dec 2023

Estimated completion

18 Aug 2027

Cervical Spinal Cord Injury

What is this study about?

This study is designed to help doctors understand more about a specific type of spinal cord injury that affects the neck (called cervical SCI). Specifically, it's for people who have an 'incomplete' injury. This means they still have some feeling or movement below the injury site, and their spine is stable, meaning they don't necessarily need immediate surgery to make it strong.

The main aim is to find better ways to measure how people are doing after this kind of injury. Doctors already use some standard tests, but this study will look at whether additional tests and measurements can give an even clearer picture of a person's recovery, especially regarding things like movement, balance, and hand use. This information is really important because it can help guide future treatments and care plans, ensuring patients get the best support for their specific needs.

Over a six-month period, participants will have regular check-ups where different assessments will be carried out. The treatment they receive (whether it's surgery or other non-surgical care) will be entirely up to their own spinal surgeon, based on what's best for them, just like for any other patient. The study simply observes their journey and collects detailed information to improve our understanding for everyone.

Key takeaways

A study for adults with specific, stable neck spinal cord injuries.
Aims to find better ways to measure recovery and improve future care.
Your treatment will be decided by your own spinal surgeon.
Involves visits at the beginning, 3 months, and 6 months.
Assessments include movement, balance, hand strength, and questionnaires.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged between 18 and 80 years old. You might be able to take part if you recently (within 92 hours) had a neck spinal cord injury from a trauma, and it falls into a specific group where you still have some feeling or movement, but your spine is stable.

It's important that your injury affects the neck area (C2-C8) and that an MRI scan shows some pressure on the spinal cord. You also need to be able to understand and agree to take part in the study. You won't be able to join if your injury wasn't from an accident, or if you have other serious health problems, including brain injuries, that might make it hard to accurately check your recovery or keep up with the study visits.

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 between 18 and 80 years old?
Did you have a neck spinal cord injury from an accident in the last 92 hours?
Does an MRI scan show pressure on your spinal cord?
Is your spinal cord injury 'incomplete' (some feeling/movement) and your spine stable?
Are you able to understand and agree to join a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have an initial check-up at the start, and then follow-up visits at 3 months and 6 months after your injury. At these visits, doctors will perform various assessments. These include checks on your neurological status (how your nerves are working), how well you can move and balance (like walking tests), and the strength and function of your hands and arms (like grip tests).

You'll also be asked to fill in some questionnaires about your health and how you feel, which helps understand your recovery from your own perspective. Some participants might also have extra MRI scans if their doctor thinks it's a good idea. All treatments, including whether you have surgery or not, will be decided by your own spinal surgeon, just as they would for any other patient. The study lasts for six months in total.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing valuable information that could improve care for future patients with similar spinal cord injuries. You will receive regular assessments, which might give you a clearer picture of your own progress. There are no direct medical treatments provided by the study, as your treatment will be decided by your own surgeon. Potential risks are generally low, mainly involving the time commitment for visits and assessments. Some assessments, like grip strength tests, might involve minor discomfort. Your rights and well-being are paramount; you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (10)

San Francisco General Hospital
Verified postcode
San Francisco, United States
UMD STC Neurosurgery Clinic
Verified postcode
Baltimore, United States
Medical college of Winsconsine, Neurosurgery
Verified postcode
Milwaukee, United States
Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo
Verified postcode
São Paulo, Brazil
St. Michael's Hospital
Verified postcode
Toronto, Canada
Toronto Western Hospital University Health Network
Verified postcode
Toronto, Canada
Vancouver Spine Research Program, Blusson Spinal Cord Centre
Verified postcode
Vancouver, Canada
BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau
Verified postcode
Murnau am Staffelsee, Germany
Indian Spinal Injuries Centre
Verified postcode
New Delhi, India
Orthopaedics, Centro Hospitalar Universitário do Porto
Verified postcode
Porto, Portugal

Common questions

What kind of spinal injury is this study for?

It's for adults with a specific type of incomplete neck (cervical) spinal cord injury caused by trauma, where the spine is stable.

Will I get special treatment if I join?

No, your treatment (surgical or non-surgical) will be decided by your own surgeon, based on standard care. The study helps gather information.

How long will I be in the study?

You'll have an initial visit, then follow-up check-ups at 3 and 6 months after your injury.

What will happen at the study visits?

Doctors will check your movement, feeling, balance, and hand strength, and you'll fill in some questionnaires.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.