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Brain-wave test may predict who wakes up after severe brain injury

NCT ID NCT07736820

Knowledge-focused Sponsor: Nicosia General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

After a severe brain injury, some patients survive but cannot communicate, and it is difficult to predict who will recover consciousness. This observational study in Cyprus is testing whether a brain-wave monitoring technique called the bispectral index (BIS) can improve predictions beyond standard bedside exams. Researchers will follow 40 patients with traumatic brain injury or haemorrhagic stroke for 6 to 12 months to see how well BIS readings correlate with later recovery of consciousness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better tools for predicting which patients with severe brain injury will regain consciousness, helping families and doctors make more informed decisions.
What could go wrong
This is a small, single-centre observational study, not a treatment trial. It is designed only to estimate effect sizes for a future larger study, so its findings may not be conclusive on their own.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive patients aged 16 years or older admitted or transferred to Nicosia General Hospital with a disorder of consciousness following moderate-to-severe traumatic brain injury or haemorrhagic stroke, who required intubation within 24 hours of the index event and who are classified as VS/UWS or MCS on the Coma Recovery Scale-Revised.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Inclusion Criteria: * Age 16 years or older * Moderate-to-severe traumatic brain injury, or haemorrhagic stroke (intracerebral or subarachnoid haemorrhage) * Intubation for a reduced level of consciousness within 24 hours of the index event * Admitted to, or transferred to, Nicosia General Hospital * Classified as VS/UWS or MCS on the Coma Recovery Scale-Revised after discharge from the intensive care unit * Written informed consent obtained from the next of kin (and from a legal guardian for participants aged 16-17) Exclusion Criteria: * Severe pre-existing psychiatric disorder * History of ischaemic or haemorrhagic stroke * Pre-existing dementia * Reduction in Glasgow Coma Scale attributable to sedation or intoxicating substances * Reduction in Glasgow Coma Scale attributable to severe extracranial injury (massive haemorrhage, generalised hypoxia) * End-stage disease with a life expectancy of less than 6 months

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Conditions

The condition(s) this trial relates to.

akinetic mutism Brain Injuries, Traumatic Coma Consciousness Disorders intracerebral hemorrhage Persistent Vegetative State subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries, traumatic Cerebral hemorrhage Coma; prolonged Consciousness disorders Minimally conscious state Persistent vegetative state Subarachnoid hemorrhage Unresponsive wakefulness syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nicosia General Hospital, Department of Neurosurgery

    Nicosia, 2029, Cyprus

More trials for these conditions

Other studies related to the condition(s) this trial covers.