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Brain injury breakthrough: new test spots hidden awareness

NCT ID NCT07456020

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two different methods to check consciousness in people with severe brain injuries. The goal is to see if a shorter, simpler test works as well as the longer standard one. About 110 patients will take part, and the results could help doctors make better treatment and care decisions.

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 110 people

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

Started

Feb 2026

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 with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.

Ages

18 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: * Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit * Underlying etiology of brain injury: anoxic, traumatic, or vascular * Time since index event \< 90 days * Early Rehabilitation Barthel Index (ERBI) score \< 30 points Exclusion Criteria: * History of prior brain injury * Pre-existing major psychiatric disorder * Impaired language comprehension (e.g., insufficient German language proficiency or aphasia) * Ongoing sedation at the time of assessment * Interruption of rehabilitation treatment (transfer to an acute care hospital) for more than 14 days * isolation precautions due to multidrug-resistant organisms

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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.

Disorders of consciousness due to severe brain injury 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

    RECRUITING

    Hessisch Oldendorf, Lower Saxony, 31840, Germany

More trials for these conditions

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