Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-11 @ 1:44 AM
Study NCT ID:
NCT02232958
Status:
TERMINATED
Last Update Posted:
2017-10-30
First Post:
2014-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Funds depleted and Ilness of Principal Investigator', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2014-09-04', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen', 'timeFrame': '4-6 weeks after treatment', 'description': 'Patients with small vessel disease of the brain will be treated with 10 hyperbaric oxygen sessions for 1 hour at 2 atmospheres absolute over the course of 2 weeks. Functional connectivity MRIs will be obtained 4-6 weeks after these sessions for comparison with those obtained before hyperbaric oxygen exposure'}], 'secondaryOutcomes': [{'measure': 'an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen', 'timeFrame': '4-6 weeks', 'description': 'NIH Neurobehavioral evaluations be obtained 4-6 weeks after exposure to 10 hyperbaric oxygen sessions of 1 hour at 2 atmospheres delivered over a period of 2 weeks. These will be compared to evaluations obtained prior to hyperbaric oxygen treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperbaric Oxygen', 'Small Vessel Disease of the Brain', 'Impaired Brain Circuit Connections'], 'conditions': ['Encephalopathy', 'White Matter Hyperintensities', 'Impaired Oxygen Delivery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to extend our previous work, in which we demonstrated an increase in the internal and cross network connectivity of resting state neural networks in patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least 20 more individuals.', 'detailedDescription': "Patients without contraindications to Hyperbaric Oxygen treatment or magnetic resonance imaging who exhibit white matter hyper-intensities on MRI will be recruited to have a functional MRI followed by10 hyperbaric oxygen treatments at 2 ATA for one hour. These treatments will be done once daily, from Monday through Friday, on 2 consecutive weeks. 4-6 weeks later, they have a repeat fMRI. These fMRI's will be analyzed regarding any changes in the resting state connectivity of various circuits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Over 50 years of age White Matter Hyperintensities on MRI @ or more symptoms and/or neurological impairments e.g. gait disturbances,disequilibrium, decline in cognitive function, upper motor neuron deficit, dysmetria, hyper-refexia or unilateral increase in motor tone -\n\nExclusion Criteria: Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema or bullae, claustrophobiia, seizure diorder Inability of the patient to tolerate pressurization e.g. Eustachian tube dysfunction Stroke within the previous 6 months Extreme cognitive impairment Major depression Other uncontrolled co-morbidities, e.g. diabetes, hypertension, thyroid disorders, carotid artery stenosis (\\>70%), renal or hepatic dysfunction History of brain tumor, head trauma, electric shock therapy, brain irradiation History of migraine headaches\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02232958', 'acronym': 'HBO', 'briefTitle': 'Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Hospital, Chesterfield, Missouri"}, 'officialTitle': 'The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease', 'orgStudyIdInfo': {'id': 'IRB #2014.011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen treatment', 'description': 'administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks', 'interventionNames': ['Other: Hyperbaric Oxygen Treatment']}], 'interventions': [{'name': 'Hyperbaric Oxygen Treatment', 'type': 'OTHER', 'description': 'Patients are placed in a special chamber in which the pressure is gradually increased up to the desired pressure with 100% Oxygen and the patient is kept at that pressure for one hour. Then the Oxygen flow is slowly reduced until the patient has been returned to one atmosphere of pressure.', 'armGroupLabels': ['Hyperbaric Oxygen treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63017', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mallinckrodt Institute of Radiology/Washington University Medical School', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'John D. Davidson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Hospital St. Louis & Washington University Medical School"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Hospital, Chesterfield, Missouri", 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Medicine Washington University School of Medicine', 'investigatorFullName': 'John Davidson', 'investigatorAffiliation': "St. Luke's Hospital, Chesterfield, Missouri"}}}}