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Oxygen chamber trial for Kids' concussion symptoms halted early

NCT ID NCT03339037

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) could help children aged 8-15 with prolonged post-concussion syndrome after a mild brain injury. The trial planned to enroll 52 participants but was terminated early. The goal was to see if the therapy improved thinking skills and reduced concussion symptoms.

What this could mean

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

Active substance
hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber)
What this could lead to
If it had worked, this could point toward a treatment to ease lingering concussion symptoms in children.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early study with no clear evidence yet.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

Nov 2017

Finished

May 2022

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 16 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: * \- Ages 8-15 * Mild TBI (defined as loss of consciousness with duration of 0-30 minutes, post-traumatic amnesia with duration of less than 24 hours, Glasgow Coma Scale grade of 13-15) within 6 months-3 years prior to the inclusion in the study. * Moderate TBI -Patients with a GCS of 9-12 a as well as additional criteria such as CT abnormalities and admission to hospital * Presence of at least two PCS as measured by the Post-Concussion Symptom Inventory )see attached) (there's a RCT now recruitingwith at least 1 and not 2) for at least 3 months. * No change in cognitive or behavioral functions during one month prior to the beginning of the study (according to parents/teachers report). Screening protocol: After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax in patients over 10, and standard pen and paper cognitive tests in patients under 10. Patients who fulfill inclusion criteria will be included in the study. Inclusion criteria: \- Objective cognitive impairment: a decrease of at least 1 standard deviation (SD) from same age mean score in one or more of the following indices : memory, attention, information processing speed, executive functions in both Neurotrax Exclusion Criteria: * \- Dynamic neurologic improvement or worsening during the past month (according to parents/teachers report); * Had been treated with HBOT for any other reason prior to their inclusion; * Chest pathology incompatible with pressure changes (including asthma) * Inner ear disease; * Claustrophobia; * Inability to perform awake brain MRI test * Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.) * Brain tumors * Skull base fractures * Active malignancy * s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, won't be excluded. * Encephalomalacia per MRI imaging * No informed consent

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic Post-Concussion Syndrome traumatic brain injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • Assaf-Harofeh Medical Center

    Ẕerifin, 70300, Israel

More trials for these conditions

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