Oxygen chamber trial for Kids' concussion symptoms halted early
NCT ID NCT03339037
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hyperbaric oxygen therapy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury
- MRI tracer could expose hidden brain energy crisis after head injury