TBI (Traumatic Brain Injury)Phase 1NCT00760734
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
A Phase 1 study testing Low pressure hyperbaric oxygen therapy in people with TBI (Traumatic Brain Injury) and Post Concussion Syndrome, run by Paul G. Harch, M.D. at 1 site in United States.
Trial summary
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Post Concussion Syndrome, Post Traumatic Stress Disorder
- What is being tested?
- Low pressure hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 1
- 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
Who may be able to join
- Adults, 18-65 years old
- One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
- Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
- Absence of intracranial neurosurgery post-TBI
- Disability Rating Scale of 0-3
- Negative Michigan Alcohol Screening Test (MAST)
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- Negative Drug Abuse Screening Test (DAST)
- Negative urine toxicology screen for drugs of abuse
- Negative pregnancy test in females
- Otherwise good health
- Less than 90% on the Percent Back to Normal Rating Scale
Who cannot join
- Pulmonary disease that precludes HBOT
- Unstable medical conditions that are contraindicated in HBOT
- Severe confinement anxiety
- Pregnancy
- Other pre-TBI neurological diagnoses
- Pre or post TBI history of substance abuse
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- Pre or post TBI history of alcoholism.
- Participation in another experimental trial with active intervention.
- High probability of inability to complete the experimental protocol.
- Previous HBOT
- History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
- Past or current history of mental retardation (baseline FSIQ < 71.
- Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
New Orleans, Louisiana, 70112
About this study
Official title: HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
- Conditions
- TBI (Traumatic Brain Injury), Post Concussion Syndrome, Post Traumatic Stress Disorder, Chronic Post Traumatic Stress Disorder
- Being tested
- Low pressure hyperbaric oxygen therapy
- Keywords
- Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pressure hyperbaric oxygen therapyDrug
Also called HBOT
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Low pressure hyperbaric oxygen therapyDrug
Also called HBOT
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy-TBI/PCS | Experimental | Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT Receives: Drug: Low pressure hyperbaric oxygen therapy |
| Hyperbaric Oxygen Therapy-PCS/PTSD | Experimental | Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT Receives: Drug: Low pressure hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric testing
Measured: 30 days
Secondary outcomes (3)
SPECT brain imaging
Measured: 30 days
Quality of life measurements
Measured: 30 days
Return to school or work
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionJun 2011
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 TBI (Traumatic Brain Injury)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul G. Harch, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Semper Fi Fund, Marine Corps-Law Enforcement Foundation, Coalition to Support America's Heroes, Thirty-eight other contributors
- Responsible party
- Sponsor-investigator, Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Paul G Harch, M.D., Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760734
- Sponsor's protocol ID
- LSU IRB #7051
- Status last verified
- Apr 2017
- First submitted
- 25 Sep 2008
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.
PubMed 22026588
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
- ClinicalTrials.gov ID
- NCT00760734
- Acronym / sponsor ID
- LSU IRB #7051
- Conditions
- TBI (Traumatic Brain Injury), Post Concussion Syndrome, Post Traumatic Stress Disorder, Chronic Post Traumatic Stress Disorder
- Keywords
- Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Paul G. Harch, M.D.University, hospital or other
- Collaborators
- Semper Fi Fund, Marine Corps-Law Enforcement Foundation, Coalition to Support America's Heroes, Thirty-eight other contributors
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Sep 2008 (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 a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy-TBI/PCS | Experimental | Drug: Low pressure hyperbaric oxygen therapyIntervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT |
| Hyperbaric Oxygen Therapy-PCS/PTSD | Experimental | Drug: Low pressure hyperbaric oxygen therapyIntervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults, 18-65 years old
- One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
- Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
- Absence of intracranial neurosurgery post-TBI
- Disability Rating Scale of 0-3
Key exclusion criteria (13 listed)
- Pulmonary disease that precludes HBOT
- Unstable medical conditions that are contraindicated in HBOT
- Severe confinement anxiety
- Pregnancy
- Other pre-TBI neurological diagnoses
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 |
|---|---|---|
| Low pressure hyperbaric oxygen therapyAlso: HBOTHBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments | Drug | Hyperbaric Oxygen Therapy-PCS/PTSD, Hyperbaric oxygen therapy-TBI/PCS |
| Low pressure hyperbaric oxygen therapyAlso: HBOTHBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments | Drug | Hyperbaric Oxygen Therapy-PCS/PTSD, Hyperbaric oxygen therapy-TBI/PCS |
Primary outcome
Psychometric testing
Time frame: 30 days
3 secondary outcomes
SPECT brain imaging
Time frame: 30 days
Quality of life measurements
Time frame: 30 days
Return to school or work
Time frame: 6 months
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 18 Apr 2017.
- Results publication: PubMed 22026588Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.
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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.
Paul G Harch, M.D. principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low pressure hyperbaric oxygen therapy in people with TBI (Traumatic Brain Injury) and Post Concussion Syndrome, run by Paul G. Harch, M.D. 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 11 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: finished, as of the sponsor's last update on 18 Apr 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Psychometric testing (time frame: 30 days). 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 NCT00760734, 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 18 Apr 2017.