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Brain Injury, ChronicPhase 2HYBOBI2NCT01986205

Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

A Phase 2 study testing Hyperbaric Oxygen and Minimal pressure air in people with Brain Injury, Chronic, run by Lindell Weaver at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Brain Injury, Chronic
What is being tested?
Hyperbaric Oxygen and Minimal pressure air
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
2 sitesUnited States
Study dates
6 Sep 2017to 31 May 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults, age 18-70 years, both men and women
  • Able to speak and read English as primary language
  • Able and willing to provide written informed consent for study participation.
  • Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol.
  • Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure.
  • Past history of at least one brain injury with persistent symptoms that meets all of the following criteria:
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  • Brain injury of non-stroke etiology that occurred at least 6 months but no more than 10 years prior to enrollment.
  • At least 3 of the following persistent symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, depression, anxiety, post-traumatic stress, or ringing in the ears.
  • Normal thyroid stimulating hormone and hematocrit value greater than 35% within the previous 6 months.

Who cannot join

  • Contraindications to hyperbaric oxygen
  • Insulin-dependent diabetes mellitus, or diabetes mellitus that is not reasonably controlled.
  • Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months).
  • Claustrophobia precluding chamber or hood tolerance.
  • Implanted devices not cleared for hyperbaric pressurization.
  • Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control during study participation.
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  • Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease that raises the risk for pulmonary barotrauma due to air trapping.
  • Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal.
  • Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygen.
  • Confounds to the outcome assessments
  • Inability to speak English as their primary language (English fluency required because many of the outcomes are only in available in English)
  • Instability with walking requiring more than a cane for assistance
  • Alcohol abuse, by self-report, within the last year.
  • Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana.
  • Failed urine drug screen during study participation.
  • Continued participation during the intervention period in sports activities where head injury is likely, such as contact football, boxing, mixed martial arts, etc.
  • Blind or deaf.
  • Major psychiatric disorder or degenerative mental disease (such as multiple sclerosis).
  • Prior therapeutic radiation to the central nervous system.
  • Personal history of any condition that pre-dates their brain injury that resulted in diminished capacity (such as chromosomal disorders) or that, in the opinion of the investigators, affects cognition to such a degree that the outcome assessments are invalidated (such as learning disability or attention deficit hyperactivity disorder requiring pharmaceutical therapy as an adult).
  • Any brain injury from stroke (ischemic or hemorrhagic)
  • Known untreated chronic or acute medical conditions, such as hypothyroidism, Cushing's disease, untreated hypertension, etc., that would confound the outcome assessments or inhibit compliance with the study protocol. If treated, these disorders would not be excluded.
  • Concomitant enrollment in any other drug/device clinical trial.
  • Prior hyperbaric oxygen for any reason within the last year.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Intermountain LDS Hospital

    Salt Lake City, Utah, 84143

Other trials in United States

About this study

Official title: A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham for Persistent Symptoms After Brain Injury

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions.

Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research.

After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.

Read the detailed description

This is a single center, randomized, double-blind study with a subsequent open-label intervention period to explore whether a course of hyperbaric oxygen can ameliorate persistent symptoms after brain injury. In this study, adult men and women with persistent symptoms 6 months to 10 years after injury will be randomized to receive 40 hyperbaric oxygen sessions (100% oxygen at 1.5 atmospheres absolute, 60 minutes door-to-door) or sham chamber sessions (room air chamber excursion at near-ambient pressure, 60 minutes door-to-door). Chamber sessions will be provided Monday through Friday, excluding holidays, and participants will have up to 12 weeks to complete their 40 sessions.

Participants will be evaluated before the chamber sessions, at 13 weeks, and at 6 months. Assessments include self-administered questionnaires, neuropsychological function, a brief neurological examination, electroencephalography, visual function tests, and a neuro-optometry evaluation. These outcome tools will measure symptoms and deficit at the time of enrollment and subsequent evaluations, and provide insight into whether hyperbaric oxygen can play a role in recovery from brain injury.

Once the participants have completed their 6 month evaluations, they will enter an open intervention group, receiving 40 hyperbaric sessions at 1.5 atmospheres absolute for 60 minutes. Participants will have up to 12 weeks to complete these sessions. Participants will be evaluated after the second set of chamber sessions (at 9 months and again at 12 months). Individuals will then be assessed annually until study closure (12-month follow-up of the last enrolled participant).

Participants will be asked to provide blood for long-term storage of serum, plasma, and DNA for future investigations, including apolipoprotein E genotype.

Being tested
Hyperbaric Oxygen, Minimal pressure air
Keywords
Concussion, Traumatic brain injury, Hyperbaric oxygenation, Post-concussion symptoms, Headache, Carbon monoxide
Medical subject headings
Brain Injury, Chronic, Brain Concussion, Brain Injuries, Traumatic, Post-Concussion Syndrome, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric OxygenCombination product

    Also called HBO2, HBOT, HBO, Hyperbaric oxygen therapy

    Hyperbaric oxygen (USP oxygen >99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.

  • Minimal pressure airCombination product

    Also called Room air

    Room air delivered in a hyperbaric chamber with minimal pressurization.

Study groups in NCT01986205
Study groupRoleWhat they receive
Hyperbaric OxygenExperimental100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions
Receives: Combination Product: Hyperbaric Oxygen
Minimal pressure airPlacebo comparatorRegular air at minimal pressurization for 60 minutes, 40 sessions
Receives: Combination Product: Minimal pressure air

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurobehavioral Symptom Inventory

    Participant-reported symptom rating of post-concussive symptoms

    Measured: 13 weeks

Secondary outcomes (2)

  1. Neurobehavioral Symptom Inventory

    Participant-reported symptom rating of post-concussive symptoms

    Measured: 6 months

  2. Incidence of myopia

    Myopic visual changes after chamber sessions

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2013 (estimated)
  2. Study start6 Sep 2017
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986205
Sponsor's protocol ID
1024845
Acronym
HYBOBI2
Status last verified
Aug 2022
First submitted
31 Oct 2013
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperbaric Oxygen and Minimal pressure air in people with Brain Injury, Chronic, run by Lindell Weaver at 2 sites 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 9 inclusion and 24 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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.

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?

Neurobehavioral Symptom Inventory (time frame: 13 weeks). 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 NCT01986205, 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 4 Aug 2022.

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