Encephalopathy, White Matter Hyperintensities, Impaired Oxygen Delivery
Conditions
Keywords
Hyperbaric Oxygen, Small Vessel Disease of the Brain, Impaired Brain Circuit Connections
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.
Interventions
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.
Sponsors
Washington University School of Medicine
St. Luke's Hospital, Chesterfield, Missouri
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen | 4-6 weeks after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen | 4-6 weeks | 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. |
Countries
United States
Outcome results
None listed