Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain InjuryPhase 1NCT00594503
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
A Phase 1 study testing Hyperbaric oxygen therapy in people with Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury, run by Paul G. Harch, M.D. at 1 site in United States.
Trial summary
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
- What is being tested?
- Hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults or children with traumatic brain injury at least one year old
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Family Physicians Center
Marrero, Louisiana, 70072
Paul G Harch, M.D., 504-309-4948, paulharchmd@gmail.com
Paul G Harch, M.D.
About this study
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.
Read the detailed description
The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.
- Conditions
- Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDrug
Total body exposure to increased atmospheric pressure oxygen
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy-TBI | Experimental | Low pressure hyperbaric oxygen therapy Receives: Drug: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECT brain imaging
Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy
Measured: After completion of HBOT
Secondary outcomes (2)
Clinical history and physical exam
Measured: After completion of HBOT
Cognitive testing
Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy
Measured: After the final HBOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neurological, Cognitive, Emotional, Behavioral Effects From 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul G. Harch, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Harch Hyperbaric Research Foundation
- 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, LSU School of Medicine, New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594503
- Sponsor's protocol ID
- LSU IRB #6625
- Status last verified
- Apr 2017
- First submitted
- 3 Jan 2008
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00594503
- Acronym / sponsor ID
- LSU IRB #6625
- Conditions
- Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Paul G. Harch, M.D.University, hospital or other
- Collaborators
- Harch Hyperbaric Research Foundation
- Study start
- Jan 2007
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jan 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.
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.
Detailed description
The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.
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 therapy-TBI | Experimental | Drug: Hyperbaric oxygen therapyLow pressure hyperbaric oxygen therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults or children with traumatic brain injury at least one year old
Key exclusion criteria (1 listed)
- None
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 therapyTotal body exposure to increased atmospheric pressure oxygen | Drug | Hyperbaric oxygen therapy-TBI |
Primary outcome
SPECT brain imaging
Time frame: After completion of HBOT
Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy
2 secondary outcomes
Clinical history and physical exam
Time frame: After completion of HBOT
Cognitive testing
Time frame: After the final HBOT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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
LSU School of Medicine, 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 Hyperbaric oxygen therapy in people with Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury, 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 1 inclusion and 1 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul G Harch, M.D. (504-309-4948, paulharchmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPECT brain imaging (time frame: After completion of HBOT). 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 18 Apr 2017.