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

• Sponsor: St. Luke's Hospital, Chesterfield, Missouri (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02232958
• Collaborator: Washington University School of Medicine (Other)
• Enrollment: 20
• Locations: 3
• Arm: 1
• Actual Duration (Months): 36.6
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Encephalopathy; White Matter Hyperintensities; Impaired Oxygen Delivery	Other: Hyperbaric Oxygen Treatment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
• Actual Study Start Date: Sep 16, 2014
• Actual Primary Completion Date: May 24, 2016
• Actual Study Completion Date: Oct 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperbaric Oxygen treatment administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks	Other: Hyperbaric Oxygen Treatment; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Hospital	Chesterfield	Missouri	United States	63017
2	St. Luke's Hospital	Saint Louis	Missouri	United States	63017
3	Mallinckrodt Institute of Radiology/Washington University Medical School	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• St. Luke's Hospital, Chesterfield, Missouri
• Washington University School of Medicine

Investigators

• Principal Investigator: John D. Davidson, MD, St. Luke's Hospital St. Louis & Washington University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Davidson, Professor of Clinical Medicine Washington University School of Medicine, St. Luke's Hospital, Chesterfield, Missouri
• ClinicalTrials.gov Identifier: NCT02232958
• Other Study ID Numbers: IRB #2014.011
• First Posted: Sep 5, 2014
• Last Update Posted: Oct 30, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by John Davidson, Professor of Clinical Medicine Washington University School of Medicine, St. Luke's Hospital, Chesterfield, Missouri: Hyperbaric Oxygen; Small Vessel Disease of the Brain; Impaired Brain Circuit Connections
• Additional relevant MeSH terms: Brain Diseases; Cerebral Small Vessel Diseases

Study Results

No Results Posted as of Oct 30, 2017