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Can a common steroid help brain injury recovery? new trial aims to find out

NCT ID NCT07180277

Disease control Sponsor: Zhangjiagang First People's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tests whether a 5-day course of the steroid methylprednisolone can improve long-term recovery in adults with moderate to severe traumatic brain injury. 520 participants will receive either the drug or a placebo, added to standard care. Researchers will measure neurological outcomes and safety at 1 and 6 months after injury.

What this could mean

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

Active substance
methylprednisolone (a steroid anti-inflammatory drug)
What this could lead to
If it works, this could provide a safe, standard treatment to improve recovery and reduce disability after traumatic brain injury.
What could go wrong
This is a Phase 4 trial, but prior steroid studies in TBI have shown mixed results or harm. The 5-day course may not improve outcomes and could increase infection risk.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 520 people

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

Started

Mar 2026

Expected to finish

Jul 2029

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.

Ages

18 to 65 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: * Age 18-65 years. * Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is 4-12. * Study drug must be initiated within 12 hours after injury. * Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma. * Written informed consent obtained from the subject or legally authorised representative. Exclusion Criteria: * Known hypersensitivity to corticosteroids or any contraindication to their use. * History of diabetes mellitus, or capillary blood glucose \<2.8 mmol/L or \>22.2 mmol/L. * Shock at admission (systolic blood pressure \<90 mmHg for more than 30 minutes). * Pregnant or lactating women. * Participation in another clinical trial within the past 3 months. * Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

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

  • Zhangjiagang First People's Hospital

    RECRUITING

    Suzhou, Jiangsu, 215600, China

More trials for these conditions

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