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Could a simple gas help heal the brain after injury?

NCT ID NCT05616910

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether inhaling nitric oxide gas can improve blood flow in the brain after a traumatic brain injury (TBI). The trial enrolls adults aged 18 to 75 with moderate TBI or mild TBI with abnormal scans. Participants receive either inhaled nitric oxide or standard care for 4 hours daily, and researchers measure brain metabolism, blood markers, and recovery over 6 months.

What this could mean

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

Active substance
inhaled nitric oxide
What this could lead to
If it works, this could point toward a new treatment to improve recovery after traumatic brain injury by restoring blood flow to the brain.
What could go wrong
This is a small early-phase trial, so results may not apply to all TBI patients. Risks include methemoglobinemia, low blood pressure, or neurological worsening.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

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

Started

Apr 2025

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.

Ages

18 to 75 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 18-75 (inclusive) 2. GCS 9-12 or GCS 13-15 with an abnormal imaging scan 3. Radiologic findings indicative of primarily diffuse TBI Exclusion Criteria: 1. Severe cardiac dysfunction (e.g. elevation of pulmonary edema on chest xray, large elevation of cardiac enzymes) 2. Large focal injury (subdural hematoma, epidural hematoma, intraparenchymal hematoma, \>30mL aggregate volume). 3. Need for immediate neurosurgical intervention 4. Pre-existing disabling psychiatric or neurological disorders such as cortical stroke, brain tumor, disabling multiple sclerosis, dementia, and severe TBI 5. Known intracranial vessel disease 6. Acute Respiratory Distress Syndrome (ARDS) or pre-existing pulmonary hypertension 7. Cardiopulmonary resuscitation or cardioversion at admission 8. Chronic Kidney Disease (Glomerular Filtration Rate \<60mL/min/1.73m2) 9. Respiratory Infection 10. Prisoners, patients in police custody, pregnant women 11. Possible drug interactions (nitric oxide donors: prilocaine, sodium nitroprusside, nitroglycerin)

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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.

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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