Hyperbaric Oxygen TherapyTBIPEDNCT03339037
Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children
A study testing Hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Traumatic Brain Injury, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Traumatic Brain Injury, Post-Concussion Syndrome
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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.
- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms.
The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated.
The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.
Read the detailed description
The study is designed as a prospective, randomized, controlled, cross-over two groups trial. The study will be conducted in the -Sagol center for hyperbaric medicine and research and the children neurological unit of Assaf Harofeh Medical Center, Israel. Brain MRIs evaluation will be done the radiology department of Assaf-Harofeh Medical Center, Israel.
Study will include 70 patients After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax and Moxo cognitive batteries. Patients who fulfill inclusion criteria will be included in the study.
After signing informed consent (by parents, at the prescreening phase), patients who fill inclusion criteria, will be randomized in 1:1 manner into the treated or the control-cross group. Randomization will be performed using a computer software according to patient id. After the randomization, patients will be invited for baseline evaluation that will include full review of their medical status and complete physical examination.
All patients will go through evaluation of their neurocognitive function using further neurocognitive testing battery, questionnaires and brain imaging (perfusion MRI+DTI, SPECT). In cases of brain tumors, skull base tumors, encephalomalacia findings in MRI, patients will be excluded.
The patients in the treated group will be evaluated three time - at baseline, after 3 months of HBOT treatment and after another consequent 3 months period from treatment (6 months from baseline). The patients of the cross group will be evaluated three times as well- at baseline, after 3 month control period without hyperbaric treatment and after a consequent 3 month period of HBOT treatment.
The following HBOT treatment protocol will be practiced: The patients will go through 60 HBOT treatments (each treatment session will be given on a separate day), distributed over three months (five days a week). Each session will be for 60 minutes in 100% oxygen atmosphere and at pressure of 1.5 ATA.
- Being tested
- Hyperbaric oxygen therapy, Normobaric air SHAM
- Keywords
- HBOT, TBI, pediatrics, PCS, PPCS, concussion, traumatic brain injury, hyperbaric oxygen
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
60 HBOT sessions at 2 ATA 100% oxygen
Normobaric air SHAMDevice
60 sessions at 1 ATA 21% oxygen (air)
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Active comparator | 60 Hyperbaric oxygen sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). each session 1.5 ATA of 100% oxygen for 1 hour.
1 meter per minute compression and decompression. Receives: Device: Hyperbaric oxygen therapy |
| Normobaric air SHAM | Sham comparator | 60 sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session at 1 ATA of 21% oxygen (air) for 1 hour.
1 meter per minute compression and decompression. after 3 months, patients will be crossed over and treated with 60 sessions of treatment Receives: Device: Normobaric air SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
Measured: at 3 months
Cognitive function
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
Measured: at 6 months
Secondary outcomes (10)
Post concussion syndrome symptoms
Patients and their parents will fill questionaries' Postconcussion Symptom Inventory (PCSI) (scale 0-21) at baseline and at their second and/or third evaluations
Measured: baseline, 3 months and 6 months from baseline
Health Behaviour inventory
Patients and their parents will fill questionaries' Health Behaviour inventory (scale 50-200) at baseline and at their second and/or third evaluations
Measured: baseline, 3 months and 6 months from baseline
Balance
Patients will undergo balance tests (BERG Balance Scale) (scale 0-56) at each of the evaluations
Measured: baseline, 3 months and 6 months from baseline
Brain functional imaging
Patients will undergo photon emission tomography (PET-CT) using FDG at each of the three evaluations
Measured: baseline, 3 months
Brain microstructural imaging
Imaging will be conducted in using a 3 Tesla system (Siemens, Germany). The MRI protocol includes the following sequences: Axial T1, T2, FLAIR, Axial Diffusion weighted, Axial T1-PostGadollinium , dynamic contrast enhancement (DSC), diffusion tensor imaging (DTI)
Measured: baseline, 3 months and 6 months from baseline
Brain perfusion
Imaging will be conducted in using a 3 Tesla system (Siemens, Germany). The MRI protocol includes the following sequences: Axial T1, T2, FLAIR, Axial Diffusion weighted, Axial T1-PostGadollinium , dynamic contrast enhancement (DSC), diffusion tensor imaging (DTI)
Measured: baseline, 3 months and 6 months from baseline
Short form health survey (PedsQL)
Patients and their parents will complete questionnaires Pediatric Quality of Life inventory (PedsQL) - multi-dimensional concept that includes domains related to physical, mental, emotional, and social functioning.
Measured: baseline, 3 months and 6 months from baseline
Brain network analysis
Patients will undergo resting state EEG as well as EEG during performing cognitive tasks ,using a 64 electrodes cap.
Measured: baseline, 3 months and 6 months from baseline
Behaviour
The parents and their teachers will complete the following questionnaire at baseline and at their second and/or third evaluations. The rating scales are available for parent (Conners 3-P), teacher (Conners 3-T) and self-report (Conners 3-SR).Subscales include inattention, hyperactivity/impulsivity, learning, executive functioning, aggression and peer relations, as well as subscales mapping onto DSM-IV criteria for ADHD (inattentive), ADHD (hyperactive-impulsive), ADHD combined, Conduct Disorder, and Oppositional-Defiant Disorder. Means and standard deviations for the global index vary dependent on age (for 6 year-olds the mean is 5.15 with a standard deviation of 3.97; means for 17 to 18 year-olds are 3.90 with a standard deviation of 4.00). Raw scores are usually converted to T-scores or percentile scores relative to normative data. T-scores above 60 (percentiles above 84) are considered clinically significant.
Measured: baseline, 3 months and 6 months from baseline
Executive functions
The parents and their teachers will complete the Behavior Rating Inventory of Executive Function(BRIEF) questionnaire at baseline and at their second and/or third evaluations.
he Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. The possible range of scores for teachers is 0 to 24.
Measured: baseline, 3 months and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2021
- Study completion20 May 2022
Why it stopped: Recruitment difficulties - patients refusal to sham controlled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized controlled trial using a SHAM treatment compared to treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339037
- Sponsor's protocol ID
- 0120-16-ASF
- Acronym
- TBIPED
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03339037
- Acronym / sponsor ID
- TBIPED / 0120-16-ASF
- Keywords
- HBOT, TBI, pediatrics, PCS, PPCS, concussion, traumatic brain injury, hyperbaric oxygen
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties - patients refusal to sham controlled
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms.
The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated.
The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.
Detailed description
The study is designed as a prospective, randomized, controlled, cross-over two groups trial. The study will be conducted in the -Sagol center for hyperbaric medicine and research and the children neurological unit of Assaf Harofeh Medical Center, Israel. Brain MRIs evaluation will be done the radiology department of Assaf-Harofeh Medical Center, Israel.
Study will include 70 patients After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax and Moxo cognitive batteries. Patients who fulfill inclusion criteria will be included in the study.
After signing informed consent (by parents, at the prescreening phase), patients who fill inclusion criteria, will be randomized in 1:1 manner into the treated or the control-cross group. Randomization will be performed using a computer software according to patient id. After the randomization, patients will be invited for baseline evaluation that will include full review of their medical status and complete physical examination.
All patients will go through evaluation of their neurocognitive function using further neurocognitive testing battery, questionnaires and brain imaging (perfusion MRI+DTI, SPECT). In cases of brain tumors, skull base tumors, encephalomalacia findings in MRI, patients will be excluded.
The patients in the treated group will be evaluated three time - at baseline, after 3 months of HBOT treatment and after another consequent 3 months period from treatment (6 months from baseline). The patients of the cross group will be evaluated three times as well- at baseline, after 3 month control period without hyperbaric treatment and after a consequent 3 month period of HBOT treatment.
The following HBOT treatment protocol will be practiced: The patients will go through 60 HBOT treatments (each treatment session will be given on a separate day), distributed over three months (five days a week). Each session will be for 60 minutes in 100% oxygen atmosphere and at pressure of 1.5 ATA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial using a SHAM treatment compared to treatment
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Active comparator | Device: Hyperbaric oxygen therapy60 Hyperbaric oxygen sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). each session 1.5 ATA of 100% oxygen for 1 hour. 1 meter per minute compression and decompression. |
| Normobaric air SHAM | Sham comparator | Device: Normobaric air SHAM60 sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session at 1 ATA of 21% oxygen (air) for 1 hour. 1 meter per minute compression and decompression. after 3 months, patients will be crossed over and treated with 60 sessions of treatment |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- - 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).
Key exclusion criteria (13 listed)
- - 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapy60 HBOT sessions at 2 ATA 100% oxygen | Device | Hyperbaric oxygen therapy |
| Normobaric air SHAM60 sessions at 1 ATA 21% oxygen (air) | Device | Normobaric air SHAM |
Primary outcome
Cognitive function
Time frame: at 3 months
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
Cognitive function
Time frame: at 6 months
General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening in patients over 10).
10 secondary outcomes
Post concussion syndrome symptoms
Time frame: baseline, 3 months and 6 months from baseline
Health Behaviour inventory
Time frame: baseline, 3 months and 6 months from baseline
Balance
Time frame: baseline, 3 months and 6 months from baseline
Brain functional imaging
Time frame: baseline, 3 months
Brain microstructural imaging
Time frame: baseline, 3 months and 6 months from baseline
Brain perfusion
Time frame: baseline, 3 months and 6 months from baseline
Short form health survey (PedsQL)
Time frame: baseline, 3 months and 6 months from baseline
Brain network analysis
Time frame: baseline, 3 months and 6 months from baseline
Behaviour
Time frame: baseline, 3 months and 6 months from baseline
Executive functions
Time frame: baseline, 3 months and 6 months from baseline
Results and safety
The study was stopped early (reason given: Recruitment difficulties - patients refusal to sham controlled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Traumatic Brain Injury, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties - patients refusal to sham controlled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.