Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-04-12 @ 8:02 PM
Study NCT ID:
NCT02105194
Status:
UNKNOWN
Last Update Posted:
2017-04-18
First Post:
2014-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-16', 'studyFirstSubmitDate': '2014-03-30', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPECT brain imaging', 'timeFrame': 'Within one month after completion of hyperbaric oxygen therapy', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Symptoms of cerebral decompression illness', 'timeFrame': 'Within one month after hyperbaric oxygen therapy', 'description': "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."}, {'measure': 'Abnormal physical exam findings', 'timeFrame': 'Within one month after hyperbaric oxygen therapy', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral decompression illness'], 'conditions': ['Cerebral Decompression Illness, All Phases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* none"}, 'identificationModule': {'nctId': 'NCT02105194', 'briefTitle': 'Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness', 'orgStudyIdInfo': {'id': 'LSU IRB #6627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric oxygen therapy', 'description': 'Hyperbaric oxygen therapy', 'interventionNames': ['Drug: Hyperbaric oxygen therapy']}], 'interventions': [{'name': 'Hyperbaric oxygen therapy', 'type': 'DRUG', 'description': 'total body exposure to greater than atmospheric pressure oxygen', 'armGroupLabels': ['Hyperbaric oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul G Harch, M.D.', 'role': 'CONTACT', 'email': 'paulharchmd@gmail.com', 'phone': '504-309-4948'}, {'name': 'Paul G Harch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Family Physicians Center', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}], 'centralContacts': [{'name': 'Paul G Harch, M.D.', 'role': 'CONTACT', 'email': 'paulharchmd@gmail.com', 'phone': '504-309-4948'}], 'overallOfficials': [{'name': 'Paul G Harch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul G. Harch, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harch Hyperbaric Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Medicine', 'investigatorFullName': 'Paul G. Harch, M.D.', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center in New Orleans'}}}}