RecruitingOBSERVATIONAL

Assessment of Consciousness With CRS-R and SECONDs

This study wants to find better and quicker ways to understand how aware someone is after a serious brain injury. Sometimes, it's hard to tell if someone is just unconscious or if they have some level of awareness. The study compares a standard, but time-consuming, test called the Coma Recovery Scale-Revised (CRS-R) with a newer, faster test called Simplified Evaluation of CONsciousness Disorders (SECONDs). The main goal is to see if SECONDs can correctly identify how aware patients are, helping doctors plan the best treatment and care. It also checks if the results from SECONDs can predict how well patients will recover in the long run. This research aims to make it easier for hospitals and rehabilitation centres to assess patients accurately.

At a glance

Status

Recruiting

Sponsor

BDH-Klinik Hessisch Oldendorf

Enrolment target

110

Start

01 Feb 2026

Estimated completion

31 Mar 2028

Disorders of Consciousness Due to Severe Brain Injury Minimally Conscious State Unresponsive Wakefulness Syndrome

What is this study about?

This study is about helping doctors better understand how aware a person is after a severe brain injury. When someone has a serious brain injury, it can be very difficult to know if they are truly unconscious, or if they have a small amount of awareness that is hard to notice. Getting this right is very important because it helps doctors decide the best care, what treatments might help, and what to expect for the future.

Currently, there's a good test called the Coma Recovery Scale-Revised (CRS-R), but it takes a lot of time to do. Because it's so long, it's not always easy to use regularly in busy hospitals. The researchers have developed a new, shorter test called SECONDs (Simplified Evaluation of CONsciousness Disorders). This new test focuses on the most important signs of awareness and aims to be just as accurate but much quicker.

This study will compare the new SECONDs test with the standard CRS-R. They want to see if SECONDs gives accurate results and if it can predict how well patients will recover over time. By finding a reliable and faster way to assess awareness, the study hopes to make it easier for healthcare teams to provide the best possible care for people recovering from severe brain injuries.

Key takeaways

Aims to find better ways to assess awareness after severe brain injury.
Compares a new, faster test (SECONDs) with a standard, longer one (CRS-R).
Hopes to improve care by providing quicker, more accurate diagnoses.
Involves assessments during rehabilitation and a follow-up call after 12 months.
Participation helps future patients with severe brain injuries.

Who may be eligible?

To be part of this study, people must have had a severe brain injury in the last three months (90 days). This injury could have been from a lack of oxygen to the brain, a head injury, or a stroke. They also need to be in an intensive care or high-dependency unit and require significant help with daily activities.

However, there are a few reasons why someone might not be able to join. They can't have had a brain injury before, or a serious mental health condition. They also need to be able to understand German well enough for the tests, and not be sedated at the time of the assessment. If their rehabilitation treatment was put on hold for more than 14 days, or if they have certain serious infections that require a special isolation, they also wouldn't be able to take part.

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.

Have you had a severe brain injury (such as from lack of oxygen, an accident, or stroke)?
Did this injury happen less than 3 months ago?
Are you currently in an intensive care or high-dependency unit?
Do you need a lot of help with daily activities?
Have you *not* had any brain injuries before, or a serious mental health condition?
Are you *not* currently sedated, and can you understand German?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main thing you'll do is have some special assessments. These will use the new SECONDs test to check your level of awareness, and possibly also the standard CRS-R test. These assessments will be done as part of your regular care in the rehabilitation centre. There are no new medicines involved in this study.

About 12 months after these initial assessments, the researchers will check in to see how you are doing. This will involve a phone call with your family member or legal representative to understand your progress and how well you are managing everyday life. The total duration of your active involvement with assessments will be relatively short during your rehabilitation stay, followed by a single follow-up contact a year later.

Potential risks and benefits

Taking part in this study involves very low risk, as the assessments are part of standard care and are not invasive. The main benefit is that participating might help healthcare professionals develop better and quicker ways to understand consciousness in people with severe brain injuries, which could lead to improved care for future patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

BDH-Klinik Hessisch Oldendorf
Verified postcode
Hessisch Oldendorf, Germany· Recruiting

Common questions

What is 'consciousness' in this study?

In this study, 'consciousness' means how aware someone is of themselves and their surroundings after a severe brain injury. It can range from being completely unaware to having some small signs of awareness.

What is a 'severe brain injury'?

This refers to serious damage to the brain, which might be caused by an accident, a stroke, or when the brain doesn't get enough oxygen, like after a heart attack.

What's the difference between the SECONDs and CRS-R tests?

The CRS-R is a widely used, thorough test for assessing awareness, but it can take a long time. SECONDs is a newer, shorter test designed to be quicker while still giving accurate results.

Will taking part change my treatment?

No, this study is about evaluating assessment tools. Your treatment and care will continue as normal, based on what your medical team believes is best for you.

Why is it important to know someone's level of consciousness?

Understanding a patient's awareness helps doctors choose the best treatments, rehabilitation plans, and gives families clearer information about what to expect for their loved one's recovery.

How to find out more

Melanie Boltzmann, PhD

m.boltzmann@bdh-klinik-hessisch-oldendorf.de +49 5152781256 Official trial record

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