The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Change in average functional connectivity (fc) within the Default Mode Network and the Dorsal Attention Network will be obtained by resting state network (rsn) functional connectivity (rsnfc) MRI.
Study Overview
Brief Summary
Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.
Detailed Description
Functional MRI studies will be done before and 4-6 weeks after Hyperbaric Oxygen treatment to assess changes in connectivity of resting state neural networks. 10 hyperbaric treatments at 2 atmospheres absolute for 1 hour at pressure will be administered. A review of symptoms and and thorough clinical neurological examination by an experienced neurologist familiar with these studies will be done before and 4-6 weeks after the hyperbaric treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •White Matter Hyperintensities on MRI
- •2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
Exclusion Criteria
- •Contraindication to hyperbaric oxygen treatment e.g. pulmonary emphysema, seizure disorder
- •major eustachian tube dysfunction
- •stroke with previous 6 months
- •extreme cognitive impairment
- •major depression
- •history of migraine, electroshock therapy, brain irradiation, brain tumor, head trauma
- •other uncontrolled co-morbidities, e.g. diabetes, renal or hepatic dysfunction, hypertension, thyroid disorders, carotid artery stenosis (>70%)
Arms & Interventions
Hyperbaric oxygen treatment
HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks
Intervention: hyperbaric oxygen treatment (Other)
Outcomes
Primary Outcomes
Change in average functional connectivity (fc) within the Default Mode Network and the Dorsal Attention Network will be obtained by resting state network (rsn) functional connectivity (rsnfc) MRI.
Time Frame: Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
Functional connectivity MRI of resting state neural networks.
Secondary Outcomes
No secondary outcomes reported
Investigators
John Davidson
Director, Division of Hyperbaric Medicine
St. Luke's Hospital, Chesterfield, Missouri