Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-31 @ 9:43 AM
Study NCT ID:
NCT00594503
Status:
UNKNOWN
Last Update Posted:
2017-04-18
First Post:
2008-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPECT brain imaging', 'timeFrame': 'After completion of HBOT', 'description': 'Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy'}], 'secondaryOutcomes': [{'measure': 'Clinical history and physical exam', 'timeFrame': 'After completion of HBOT'}, {'measure': 'Cognitive testing', 'timeFrame': 'After the final HBOT', 'description': 'Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['traumatic brain injury'], 'conditions': ['Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults or children with traumatic brain injury at least one year old\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00594503', 'briefTitle': 'Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'LSU IRB #6625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric oxygen therapy-TBI', 'description': 'Low pressure hyperbaric oxygen therapy', 'interventionNames': ['Drug: Hyperbaric oxygen therapy']}], 'interventions': [{'name': 'Hyperbaric oxygen therapy', 'type': 'DRUG', 'description': 'Total body exposure to increased atmospheric pressure oxygen', 'armGroupLabels': ['Hyperbaric oxygen therapy-TBI']}]}, '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, New Orleans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}