Traumatic Brain InjuryNBIRR-1NCT01105962
Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder
An observational study of Traumatic Brain Injury and Post-traumatic Stress Disorder, run by International Hyperbaric Medical Foundation at 10 sites in United States.
Trial summary
This is an observational research study whose purposes are to see: 1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Post-traumatic Stress Disorder
- How many people
- 133 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2010to Mar 2015
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores. There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction. All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study. Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.
Who may be able to join
- Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
- Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
- Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
- Negative pregnancy test in females.
- Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).
Who cannot join
- Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
- Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
- Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
- Pregnancy.
- Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
- Participation in another experimental trial with active intervention.
Show all 10Show fewer
- High probability of inability to complete the experimental protocol (e.g. terminal condition).
- Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
- Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
- Any pre-existing chronic infection not related to battlefield injuries or government service.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alliance Community Hospital Wound Care and Hyperbaric Department
Alliance, Ohio, 44601
Rocky Mountain Hyperbaric Institute
Boulder, Colorado, 80301
Hyperbaric Services of the Palm Beaches
Delray Beach, Florida, 33484
Fox Valley Wellness Center
Fond du Lac, Wisconsin, 54935
Hyperbaric Medicine Inc. of Florida
Fort Walton Beach, Florida, 32547
Hyperbaric Institute of Nevada and Clinical Neurology Specialists
Henderson, Nevada, 89012
Lifeforce Therapies
Plymouth, Minnesota, 55447
Idaho Wound Care & Hyperbaric Medicine
Pocatello, Idaho, 83201
HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
Reston, Virginia, 20190
San Francisco Institute for Hyperbaric Medicine
San Francisco, California, 94107
About this study
Official title: Multicenter Observational Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and/or TBI/Post-Traumatic Stress Disorder (PTSD)
This is an observational research study whose purposes are to see:
- if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
- if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
- determine the long-term outcome of the treatment.
- confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies
- Keywords
- traumatic, brain, injury, post-traumatic, stress, hyperbaric, oxygen, HBOT, TBI, PTSD
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Measured: 2-6mo then every 6 months for 2yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: new regulatory requirements will require funding for restart as a new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hyperbaric Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- B Robert Mozayeni, MD, Study director, International Hyperbaric Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105962
- Sponsor's protocol ID
- NBIRR-01
- Acronym
- NBIRR-1
- Status last verified
- Sep 2016
- First submitted
- 15 Apr 2010
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and/or TBI/Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01105962
- Acronym / sponsor ID
- NBIRR-1 / NBIRR-01
- Keywords
- traumatic, brain, injury, post-traumatic, stress, hyperbaric, oxygen, HBOT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: new regulatory requirements will require funding for restart as a new study
- Enrolment
- 133 participants (actual)
- Lead sponsor
- International Hyperbaric Medical FoundationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Apr 2010 (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.
This is an observational research study whose purposes are to see:
- if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
- if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
- determine the long-term outcome of the treatment.
- confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores. There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction. All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study. Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.
Key inclusion criteria (5 listed)
- Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
- Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
- Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
- Negative pregnancy test in females.
- Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).
Key exclusion criteria (10 listed)
- Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
- Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
- Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
- Pregnancy.
- Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Function
Time frame: 2-6mo then every 6 months for 2yrs
Results and safety
The study was stopped early (reason given: new regulatory requirements will require funding for restart as a new study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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.
B Robert Mozayeni, MD study director
International Hyperbaric Medical Foundation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Post-traumatic Stress Disorder, run by International Hyperbaric Medical Foundation at 10 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 5 inclusion and 10 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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: new regulatory requirements will require funding for restart as a new study). 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: 2-6mo then every 6 months for 2yrs). 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 20 Sep 2016.