Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT00760734
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D038223', 'term': 'Post-Concussion Syndrome'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-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'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-16', 'studyFirstSubmitDate': '2008-09-25', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychometric testing', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'SPECT brain imaging', 'timeFrame': '30 days'}, {'measure': 'Quality of life measurements', 'timeFrame': '30 days'}, {'measure': 'Return to school or work', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic traumatic brain injury', 'Post concussion syndrome', 'Post traumatic stress disorder', 'Chronic post traumatic stress disorder'], 'conditions': ['TBI (Traumatic Brain Injury)', 'Post Concussion Syndrome', 'Post Traumatic Stress Disorder', 'Chronic Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '22026588', 'type': 'RESULT', 'citation': 'Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults, 18-65 years old\n* One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001\n* Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.\n* Absence of intracranial neurosurgery post-TBI\n* Disability Rating Scale of 0-3\n* Negative Michigan Alcohol Screening Test (MAST)\n* Negative Drug Abuse Screening Test (DAST)\n* Negative urine toxicology screen for drugs of abuse\n* Negative pregnancy test in females\n* Otherwise good health\n* Less than 90% on the Percent Back to Normal Rating Scale\n\nExclusion Criteria:\n\n* Pulmonary disease that precludes HBOT\n* Unstable medical conditions that are contraindicated in HBOT\n* Severe confinement anxiety\n* Pregnancy\n* Other pre-TBI neurological diagnoses\n* Pre or post TBI history of substance abuse\n* Pre or post TBI history of alcoholism.\n* Participation in another experimental trial with active intervention.\n* High probability of inability to complete the experimental protocol.\n* Previous HBOT\n* History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI\n* Past or current history of mental retardation (baseline FSIQ \\< 71.\n* Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)"}, 'identificationModule': {'nctId': 'NCT00760734', 'briefTitle': 'Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial', 'orgStudyIdInfo': {'id': 'LSU IRB #7051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric oxygen therapy-TBI/PCS', 'description': 'Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT', 'interventionNames': ['Drug: Low pressure hyperbaric oxygen therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen Therapy-PCS/PTSD', 'description': 'Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT', 'interventionNames': ['Drug: Low pressure hyperbaric oxygen therapy']}], 'interventions': [{'name': 'Low pressure hyperbaric oxygen therapy', 'type': 'DRUG', 'otherNames': ['HBOT'], 'description': 'HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments', 'armGroupLabels': ['Hyperbaric Oxygen Therapy-PCS/PTSD', 'Hyperbaric oxygen therapy-TBI/PCS']}, {'name': 'Low pressure hyperbaric oxygen therapy', 'type': 'DRUG', 'otherNames': ['HBOT'], 'description': 'HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments', 'armGroupLabels': ['Hyperbaric Oxygen Therapy-PCS/PTSD', 'Hyperbaric oxygen therapy-TBI/PCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Paul G Harch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louisiana State University Health Sciences Center in New Orleans'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul G. Harch, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Semper Fi Fund', 'class': 'UNKNOWN'}, {'name': 'Marine Corps-Law Enforcement Foundation', 'class': 'OTHER'}, {'name': "Coalition to Support America's Heroes", 'class': 'UNKNOWN'}, {'name': 'Thirty-eight other contributors', 'class': 'UNKNOWN'}], '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'}}}}