Brain InjuryPhase 2HYBOBINCT00830453
Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
A Phase 2 study testing Hyperbaric oxygen therapy (HBO2) in people with Brain Injury and Sequelae, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injury, Sequelae, Stroke
- What is being tested?
- Hyperbaric oxygen therapy (HBO2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Dec 2010
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has had a brain injury at least 12 months prior to study enrollment.
- Subject is at least 18 years old.
- Etiology of brain injury: Stroke, anoxia, and trauma
- Must be able to equalize ears, or have tympanostomy tubes
- Willingness to complete outcome measures and complies with the research protocols.
- Commitment to pay the hospital for hyperbaric oxygen.
Who cannot join
- Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation.
- Poorly controlled seizures(ie:>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an exclusion to participate.
- Inability to participate in outcome assessments (eg: blindness, quadraplegia)
- Claustrophobia (unwillingness or inability to enter the hyperbaric chamber).
- Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes.
- Inability to protect airway, and or requiring frequent suctioning.
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- Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber.
- Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment).
- Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not exclude patients based on brain-injury induced psychiatric disorders, but will exclude patients with severe pre-injury psychiatric disorders.
- Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability).
- Degenerative Mental Disease (eg: Alzheimer's, multiple sclerosis, senile dementia, severe psychiatric disorder (schizophrenia, bi-polar disease, etc.).
- Presence of chronic debilitating disease (end-stage renal disease, end-stage liver disease, diabetes with sequelae).
- Heart failure patients with ejection fractions less than 50% or inability to lay supine.
- Patients with active malignancy, or prior treatment with cisplatin or bleomycin (there is some evidence that prior cisplatin and bleomycin therapy may place the patient at increased risk for serious oxidated stress with inhalation of high concentrations of oxygen).
- Evidence of current recreational drug use, either by history, or by comprehensive urine drug testing (due to confounds on outcome measure interpretation).
- Consumption of more than the equivalent of 12 beers/week habitually.
- Prior treatment with hyperbaric oxygen for chronic brain injury within the last year.
- Women of child-bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. This study will also look at the outcome of individuals with a chronic stable brain injury due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength, etc.) measures will be performed before the hyperbaric sessions, immediately following them, and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
Read the detailed description
Hyperbaric oxygen is presently being used in an attempt to improve functional outcome following a multitude of brain injuries such as stroke, anoxic brain injury, traumatic brain injury, and others. Family members of brain-injured individuals correspond via the Internet into coalitions demanding that their loved ones receive hyperbaric oxygen therapy. There are anecdotal reports of benefit with hyperbaric oxygen following brain injury but there is little credible scientific evidence for efficacy of hyperbaric oxygen in brain injury. Clearly, what is needed to answer if hyperbaric oxygen improves brain injury are results from carefully designed multi-center, prospective, randomized controlled clinical trials. However, the implementation of such a Phase III clinical trial is challenging without information from Phase II trials. We propose to conduct a feasibility trial that may potentially guide a future Phase III clinical trial.
Mechanisms by which hyperbaric oxygen improves sequelae following brain injury are speculative. Hyperbaric oxygen upregulates growth factor receptor sites on human endothelium and can stimulate healing in hypoxic wounds. It is conceivable that hyperbaric oxygen exerts similar effects within damaged neuronal tissue but this information is lacking. Stem cells are present in the adult brain and there is speculation that hyperbaric oxygen may stimulate these stem cells to generate new neurons, but once again, this information is speculative.
In this Phase II feasibility prospective clinical trial, we propose to recruit and enroll 70 brain-injured subjects and expose them daily to hyperbaric oxygen at 1.5 atmospheres absolute for 60 minutes per session, for 60 sessions per subject. This research protocol is the one most commonly used by practitioners who claim benefit with hyperbaric oxygen therapy. Before and after the 60 hyperbaric oxygen sessions, and at 6 months following completion of hyperbaric oxygen, outcome measures consisting of neuropsychological testing, functional measures, health-related quality of life measures, and a neurological examination will be conducted and analyzed with the subjects serving as their own controls. Important information regarding a subsequent Phase III clinical trial, including subject recruitment, tolerance and risk of therapy, dropout rate, and potential benefit or lack of benefit with hyperbaric oxygen will be reported.
- Conditions
- Brain Injury, Sequelae, Stroke, Anoxia, Trauma
- Being tested
- Hyperbaric oxygen therapy (HBO2)
- Keywords
- Brain injury with sequelae from stroke, anoxia, or trauma
- Medical subject headings
- Brain Injuries, Stroke, Hypoxia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapy (HBO2)Procedure or surgery
60 daily hyperbaric oxygen sessions 1.5 atmospheres absolute, 100% oxygen 60 minutes per session, from door closing to door opening
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen | Experimental | Hyperbaric oxygen, 1.5 atmospheres absolute, 60 minutes door-to-door, 60 daily sessions. Receives: Procedure: Hyperbaric oxygen therapy (HBO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
With this feasibility trial we wish to determine if we can recruit suitable subjects and if they will be able to comply with the protocol and tolerate 60 hyperbaric oxygen sessions.
Measured: Immediately following completion of final hyperbaric oxygen session
Secondary outcomes (1)
To estimate the immediate and long-term effects of hyperbaric oxygen therapy on subjects with chronic brain injury. This feasibility trial may be underpowered to demonstrate efficacy, or not, with hyperbaric oxygen.
Measured: Outcome measures performed immediately after final hyperbaric oxygen session and 6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startNov 2003
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Responsible party
- Sponsor
- Investigators
- Susan K. Churchill, APRN-NP, Principal investigator, Intermountain Health Care, Inc.Lindell K. Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830453
- Sponsor's protocol ID
- 950-352
- Acronym
- HYBOBI
- Status last verified
- Sep 2011
- First submitted
- 27 Jan 2009
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Churchill S, Weaver LK, Deru K, Russo AA, Handrahan D, Orrison WW Jr, Foley JF, Elwell HA. A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI). Undersea Hyperb Med. 2013 Mar-Apr;40(2):165-93.
PubMed 23682548
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
- ClinicalTrials.gov ID
- NCT00830453
- Acronym / sponsor ID
- HYBOBI / 950-352
- Conditions
- Brain Injury, Sequelae, Stroke, Anoxia, Trauma
- Keywords
- Brain injury with sequelae from stroke, anoxia, or trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- Nov 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jan 2009 (estimated)
- 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.
The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. This study will also look at the outcome of individuals with a chronic stable brain injury due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength, etc.) measures will be performed before the hyperbaric sessions, immediately following them, and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
Detailed description
Hyperbaric oxygen is presently being used in an attempt to improve functional outcome following a multitude of brain injuries such as stroke, anoxic brain injury, traumatic brain injury, and others. Family members of brain-injured individuals correspond via the Internet into coalitions demanding that their loved ones receive hyperbaric oxygen therapy. There are anecdotal reports of benefit with hyperbaric oxygen following brain injury but there is little credible scientific evidence for efficacy of hyperbaric oxygen in brain injury. Clearly, what is needed to answer if hyperbaric oxygen improves brain injury are results from carefully designed multi-center, prospective, randomized controlled clinical trials. However, the implementation of such a Phase III clinical trial is challenging without information from Phase II trials. We propose to conduct a feasibility trial that may potentially guide a future Phase III clinical trial.
Mechanisms by which hyperbaric oxygen improves sequelae following brain injury are speculative. Hyperbaric oxygen upregulates growth factor receptor sites on human endothelium and can stimulate healing in hypoxic wounds. It is conceivable that hyperbaric oxygen exerts similar effects within damaged neuronal tissue but this information is lacking. Stem cells are present in the adult brain and there is speculation that hyperbaric oxygen may stimulate these stem cells to generate new neurons, but once again, this information is speculative.
In this Phase II feasibility prospective clinical trial, we propose to recruit and enroll 70 brain-injured subjects and expose them daily to hyperbaric oxygen at 1.5 atmospheres absolute for 60 minutes per session, for 60 sessions per subject. This research protocol is the one most commonly used by practitioners who claim benefit with hyperbaric oxygen therapy. Before and after the 60 hyperbaric oxygen sessions, and at 6 months following completion of hyperbaric oxygen, outcome measures consisting of neuropsychological testing, functional measures, health-related quality of life measures, and a neurological examination will be conducted and analyzed with the subjects serving as their own controls. Important information regarding a subsequent Phase III clinical trial, including subject recruitment, tolerance and risk of therapy, dropout rate, and potential benefit or lack of benefit with hyperbaric oxygen will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen | Experimental | Procedure: Hyperbaric oxygen therapy (HBO2)Hyperbaric oxygen, 1.5 atmospheres absolute, 60 minutes door-to-door, 60 daily sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has had a brain injury at least 12 months prior to study enrollment.
- Subject is at least 18 years old.
- Etiology of brain injury: Stroke, anoxia, and trauma
- Must be able to equalize ears, or have tympanostomy tubes
- Willingness to complete outcome measures and complies with the research protocols.
Key exclusion criteria (18 listed)
- Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation.
- Poorly controlled seizures(ie:>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an exclusion to participate.
- Inability to participate in outcome assessments (eg: blindness, quadraplegia)
- Claustrophobia (unwillingness or inability to enter the hyperbaric chamber).
- Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes.
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 therapy (HBO2)60 daily hyperbaric oxygen sessions 1.5 atmospheres absolute, 100% oxygen 60 minutes per session, from door closing to door opening | Procedure or surgery | Hyperbaric oxygen |
Primary outcome
With this feasibility trial we wish to determine if we can recruit suitable subjects and if they will be able to comply with the protocol and tolerate 60 hyperbaric oxygen sessions.
Time frame: Immediately following completion of final hyperbaric oxygen session
1 secondary outcome
To estimate the immediate and long-term effects of hyperbaric oxygen therapy on subjects with chronic brain injury. This feasibility trial may be underpowered to demonstrate efficacy, or not, with hyperbaric oxygen.
Time frame: Outcome measures performed immediately after final hyperbaric oxygen session and 6 months later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Derived from this study: PubMed 23682548Churchill S, Weaver LK, Deru K, Russo AA, Handrahan D, Orrison WW Jr, Foley JF, Elwell HA. A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI). Undersea Hyperb Med. 2013 Mar-Apr;40(2):165-93.
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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.
Susan K. Churchill, APRN-NP principal investigator
Intermountain Health Care, Inc.
Lindell K. Weaver, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric oxygen therapy (HBO2) in people with Brain Injury and Sequelae, run by Intermountain Health Care, Inc. at 1 site in United States.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 15 Feb 2021. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
With this feasibility trial we wish to determine if we can recruit suitable subjects and if they will be able to comply with the protocol and tolerate 60 hyperbaric oxygen sessions. (time frame: Immediately following completion of final hyperbaric oxygen session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830453, which also lists 1 linked publication.
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 15 Feb 2021.