Cerebral Decompression Illness, All PhasesPhase 1NCT02105194
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness
A Phase 1 study testing Hyperbaric oxygen therapy in people with Cerebral Decompression Illness, All Phases, run by Paul G. Harch, M.D. at 1 site in United States.
Trial summary
Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Decompression Illness, All Phases
- 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
- All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.
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
Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.
Read the detailed description
SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- cerebral decompression illness
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 greater than atmospheric pressure oxygen
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | 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
Comparison of SPECT brain imaging chart copy of radiological reading before or early in the treatment history to SPECT brain imaging chart copy of radiological reading after treatment. Imaging will be scored as better, worse, or no change based on resolution of defects or improvement in pattern of injury.
Measured: Within one month after completion of hyperbaric oxygen therapy
Secondary outcomes (2)
Symptoms of cerebral decompression illness
Chart reports of patients' symptoms of cerebral decompression illness before hyperbaric oxygen therapy will be compared to symptoms after hyperbaric oxygen therapy and rated as better, worse, or no change.
Measured: Within one month after hyperbaric oxygen therapy
Abnormal physical exam findings
Chart reports of abnormal physical exam findings before hyperbaric oxygen therapy will be compared to chart reports of physical exam findings after hyperbaric oxygen therapy and rated as better, worse, or no change.
Measured: Within one month after hyperbaric oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (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 Cerebral Decompression Illness, All PhasesStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105194
- Sponsor's protocol ID
- LSU IRB #6627
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2014
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- 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 Cerebral Decompression Illness
- ClinicalTrials.gov ID
- NCT02105194
- Acronym / sponsor ID
- LSU IRB #6627
- Keywords
- cerebral decompression illness
- 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
- 7 Apr 2014 (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.
Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.
Detailed description
SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.
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 | Experimental | Drug: Hyperbaric oxygen therapyHyperbaric oxygen therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.
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 greater than atmospheric pressure oxygen | Drug | Hyperbaric oxygen therapy |
Primary outcome
SPECT brain imaging
Time frame: Within one month after completion of hyperbaric oxygen therapy
Comparison of SPECT brain imaging chart copy of radiological reading before or early in the treatment history to SPECT brain imaging chart copy of radiological reading after treatment. Imaging will be scored as better, worse, or no change based on resolution of defects or improvement in pattern of injury.
2 secondary outcomes
Symptoms of cerebral decompression illness
Time frame: Within one month after hyperbaric oxygen therapy
Abnormal physical exam findings
Time frame: Within one month after hyperbaric oxygen therapy
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.
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
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 Cerebral Decompression Illness, All Phases, 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: Within one month after completion of hyperbaric oxygen therapy). 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.