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Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness

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ClinicalTrials.gov Identifier: NCT02105194
Recruitment Status : Unknown
Verified April 2017 by Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Recruiting
First Posted : April 7, 2014
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Harch Hyperbaric Research Foundation
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Decompression Illness, All Phases Drug: Hyperbaric oxygen therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness
Study Start Date : January 2007
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy
Drug: Hyperbaric oxygen therapy
total body exposure to greater than atmospheric pressure oxygen




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Symptoms of cerebral decompression illness [ Time Frame: Within one month after hyperbaric oxygen therapy ]
    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.

  2. Abnormal physical exam findings [ Time Frame: Within one month after hyperbaric oxygen therapy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105194


Contacts
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Contact: Paul G Harch, M.D. 504-309-4948 paulharchmd@gmail.com

Locations
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United States, Louisiana
Family Physicians Center Recruiting
Marrero, Louisiana, United States, 70072
Contact: Paul G Harch, M.D.    504-309-4948    paulharchmd@gmail.com   
Principal Investigator: Paul G Harch, M.D.         
Sponsors and Collaborators
Paul G. Harch, M.D.
Harch Hyperbaric Research Foundation
Investigators
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Principal Investigator: Paul G Harch, M.D. LSU School of Medicine

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Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02105194     History of Changes
Other Study ID Numbers: LSU IRB #6627
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans:
cerebral decompression illness