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Brain wave test may unlock hidden awareness in coma patients

NCT ID NCT07455682

Knowledge-focused Sponsor: BDH-Klinik Hessisch Oldendorf Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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.
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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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether an EEG (a brain wave test) can better tell the difference between people who are unresponsive but awake and those who show minimal signs of awareness after a severe brain injury. About 42 adults will take part. The goal is to see if brain responses to sounds can predict recovery a year later.

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 42 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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

The study population consists of adult patients (18-80 years) with severe acquired brain injury in the subacute phase who are diagnosed with a disorder of consciousness (Unresponsive Wakefulness Syndrome or Minimally Conscious State) in a neurological rehabilitation setting.

Ages

18 to 80 years

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: * Presence of a disorder of consciousness (Unresponsive Wakefulness Syndrome \[UWS\] or Minimally Conscious State \[MCS\]), classified using the Coma Recovery Scale-Revised (CRS-R) based on three assessments conducted on at least two separate days * Age between 18 and 80 years * Written informed consent provided by the patient's legal representative * Preserved brainstem auditory evoked potentials (BAEPs) on at least one side Exclusion Criteria: * Ongoing sedation at the time of EEG assessment * Current treatment with medications known to significantly affect cortical functional state, including barbiturates, neuroleptics (antipsychotics), antiepileptic drugs, benzodiazepines, or comparable agents * Colonization with multidrug-resistant organisms requiring isolation precautions (e.g., 4MRGN) * Pregnancy * Impaired language comprehension (e.g., insufficient German language proficiency or aphasia) * Temporal bone fractures or severe infratentorial brain injury associated with unilateral or bilateral absence of auditory evoked potentials (AEPs) * Bilateral hearing impairment or deafness, or presence of a cochlear implant * Scalp wounds or conditions preventing placement of an EEG electrode cap

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Conditions

The condition(s) this trial relates to.

akinetic mutism brain injury Consciousness Disorders Persistent Vegetative State

As listed by the trial registrant

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

Disorder of consciousness Minimally conscious state 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

  • BDH-Klinik Hessisch Oldendorf

    Hessisch Oldendorf, Lower Saxony, 31840, Germany

More trials for these conditions

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