RecruitingOBSERVATIONAL

The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

This study, called I-SCRIBBLE, is trying to find out if certain markers in your blood, called NF-L and GFAP, can help predict how much recovery someone will make after a spinal cord injury. These markers are like tiny signals in your body that might show how severe an injury is. Researchers will take blood samples from people with spinal cord injuries at different times after their accident, up to a year later. They will also do some simple tests to check movement and daily activities. The goal is to see if measuring these blood markers can help doctors better understand and predict a person's recovery, potentially leading to better care in the future. A separate group of people with spine injuries but no nerve damage will also take part as a comparison.

At a glance

Status

Recruiting

Sponsor

AO Foundation, AO Spine

Enrolment target

260

Start

09 Feb 2026

Estimated completion

01 Dec 2029

Spinal Cord Injury

What is this study about?

Imagine your body has tiny alarm bells that ring when something is damaged. This study is looking at two specific 'alarm bells' called NF-L and GFAP, which are found in your blood after a spinal cord injury. The researchers want to see if the levels of these alarm bells in your blood can help predict how much you might recover after your injury. For example, will you be able to move your arms and legs better, or do daily tasks more easily?

To do this, they will collect blood samples from people who have had a spinal cord injury at various times after their accident – starting within 24 hours and continuing up to a year later. They will also do some simple physical checks to see how well you can move and function. By comparing these blood levels with your recovery, they hope to learn if these blood markers can give doctors an early idea of how serious the injury is and what the future might hold.

This research is important because if doctors can predict recovery more accurately, it could help them give more personalized care and advice. It might also help develop new treatments in the future. The study also includes people who have a spinal injury but no nerve damage, to help the researchers understand the normal levels of these markers when there isn't a spinal cord injury.

Key takeaways

The study investigates blood markers (NF-L and GFAP) that may predict recovery after spinal cord injury.
Participation involves giving blood samples at various times over a year.
Your movement and daily activities will also be assessed.
The goal is to improve understanding and future care for spinal cord injury patients.
There are no direct medical benefits for participants in this study.
You can withdraw from the study at any time without affecting your ongoing care.

Who may be eligible?

You might be able to take part in this study if you are 19 years or older and have recently experienced a blunt (not caused by a piercing object like a bullet or knife) spinal cord injury. Your injury must be between the neck (C0) and lower back (L1) areas. It's also important that your first blood sample can be collected within 24 hours of your injury.

The study also includes a comparison group. You could be in this group if you're 19 or older and have a spinal fracture or dislocation between your neck and lower back, but without any damage to your spinal cord itself and also able to have initial blood sample taken within 24 hours of injury.

You would not be able to join if your injury was caused by a piercing object, if you've had a spinal cord injury before, or if your injury is below the L1 level. Certain medical conditions like multiple sclerosis, or problems with blood clotting, might also mean you can't take part. The research team also needs to be sure you can safely follow the study's procedures.

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 19 years old or older?
Did your spinal cord injury happen recently (within the last 24 hours for the first blood test)?
Was your injury not caused by a bullet or knife?
Is your injury between your neck (C0) and lower back (L1) area?
Do you not have a pre-existing condition like Bultiple Sclerosis or clotting disorders?
Can you understand and give permission to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is providing an initial blood sample within 24 hours of your injury. After that, you'll have more blood samples taken daily for the first week. Then, there will be further blood draws at 6 months and 12 months after your injury. These blood samples will usually be taken from existing lines (like those used for drips) already in place, but sometimes a small needle in your arm might be used if needed. Each time, about 15ml of blood will be taken, which is roughly a tablespoon.

Besides blood samples, you'll have some simple physical checks. At the very beginning, and again at 6 and 12 months, you'll have a full check of your movement and sensation. On day 4 and day 7 after your injury, there will be a shorter check just focusing on your movement. At the 6 and 12-month visits, you'll also complete a questionnaire about how well you're managing daily activities. There are no study medications involved.

Potential risks and benefits

Taking part in this study does not offer a direct medical benefit to you right now, but your contribution could help researchers learn more about spinal cord injuries, potentially leading to better care for others in the future. The main risks involve some discomfort from blood draws, especially if a new venipuncture (needle stick in the arm) is needed, and a very small risk of bruising or infection, similar to any routine blood test. Your decision to take part is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medical College of Wisconsin
Verified postcode
Milwaukee, United States· Recruiting
Prince of Wales Hospital
Verified postcode
Sydney, Australia· Not yet recruiting
Cajuru University Hospital
Verified postcode
Curitiba, Brazil· Not yet recruiting
Clinica Alemana de Santiago
Verified postcode
Santiago, Chile· Recruiting
Charité Berlin
Verified postcode
Berlin, Germany· Not yet recruiting
Sri Balaji Action Medical Institute
Verified postcode
New Delhi, India· Not yet recruiting
MIddlemore Hospital
Verified postcode
Auckland, New Zealand· Not yet recruiting
King's College Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What are NF-L and GFAP?

They are tiny markers, like signals, found in your blood that might show how severe a spinal cord injury is.

How often will I give blood?

You'll provide blood daily for the first week, then again at 6 months and 12 months after your injury.

Will I have to do any special exercises or take new medicines?

No, there are no special exercises or new medications as part of this study.

Will this study help me recover faster?

This study won't directly change your recovery, but it helps researchers understand spinal cord injuries better for future treatments.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it won't affect your medical care.

How to find out more

Alix Frischknecht

alix.frischknecht@aofoundation.org +41 79 606 41 48 Official trial record

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