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Can brainwave and blood flow data forecast who wakes after a severe brain injury?

NCT ID NCT07115459

Knowledge-focused Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers at Xiangya Hospital are building a tool that uses several types of brain monitoring to predict whether patients with severe acute brain injury will be awake, comatose, or deceased 90 days after ICU admission. The study enrolls 200 adults aged 18 to 80 with conditions such as large strokes, brain hemorrhages, or severe traumatic brain injury. Participants receive standard monitoring including EEG, transcranial Doppler, and near-infrared spectroscopy, and researchers track their outcomes. The study is observational, so no experimental treatments are given.

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 the model works, doctors could use routine brain monitoring data to give families a clearer picture of recovery odds and tailor treatment sooner.
What could go wrong
This observational study only builds and tests a prediction tool, so it cannot prove that acting on its predictions improves outcomes. The model may not work well in hospitals with different equipment or patient mix.

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 200 people

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

Started

Jan 2024

Expected to finish

Dec 2027

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

Neurocritical patients aged 18-80 years with acute brain injury admitted to the ICU.

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: 1. Aged 18-80 years, no gender restrictions. 2. Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis. 3. On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8). 4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours. 5. Informed consent signed by the family or legal representative. Exclusion Criteria: 1. Confirmed brain death on admission or imaging showing irreversible brain herniation. 2. Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment. 3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus). 4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems). 5. Predicted survival time \<24 hours after admission, or family members choose to withdraw treatment. 6. Refusal to participate in the study by the patient or their legal representative.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic cerebral infarction intracerebral hemorrhage Intracranial Hemorrhages subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

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

Acute brain injury coma Cerebral infarction Intracranial hemorrhages Neurocritical care Severe traumatic brain injury Subarachnoid hemorrhage

How to take part

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  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

  • XiangyaHospital of Central South University

    RECRUITING

    Changsha, Hunan, 410080, China

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