Clinical trial NCT02232958: Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease
Official title: The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Encephalopathy
White Matter Hyperintensities
Impaired Oxygen Delivery
Keywords: Hyperbaric Oxygen
Small Vessel Disease of the Brain
Impaired Brain Circuit Connections
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2014-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 -

Exclusion 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

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Primary outcomes:
measure: Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen
timeFrame: 4-6 weeks after treatment
Secondary outcomes:
measure: an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology/Washington University Medical School
state: Missouri
Study officials:
affiliation: St. Luke's Hospital St. Louis & Washington University Medical School
name: John D. Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: