Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease

Not Applicable

Terminated

• Conditions: White Matter Hyperintensities; Encephalopathy; Impaired Oxygen Delivery
• Interventions: Other: Hyperbaric Oxygen Treatment

• Registration Number: NCT02232958
• Lead Sponsor: St. Luke's Hospital, Chesterfield, Missouri

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.

Study Timeline

• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-05
• Study Start: 2014-09-16
• Primary Completion: 2016-05-24
• Status Verified: 2017-10
• Study Completion: 2017-10-04
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen treatment	Hyperbaric Oxygen Treatment	administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Mallinckrodt Institute of Radiology/Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States

St. Luke's Hospital; 🇺🇸 Saint Louis, Missouri, United States