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

NCT ID: NCT02232958

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-16

Study Completion Date

2017-10-04

Brief Summary

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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

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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.

Conditions

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Encephalopathy White Matter Hyperintensities Impaired Oxygen Delivery

Keywords

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Hyperbaric Oxygen Small Vessel Disease of the Brain Impaired Brain Circuit Connections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric Oxygen treatment

administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks

Group Type EXPERIMENTAL

Hyperbaric Oxygen Treatment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role collaborator

St. Luke's Hospital, Chesterfield, Missouri

OTHER

Sponsor Role lead

Responsible Party

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John Davidson

Professor of Clinical Medicine Washington University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D. Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital St. Louis & Washington University Medical School

Locations

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St. Luke's Hospital

Chesterfield, Missouri, United States

Site Status

St. Luke's Hospital

St Louis, Missouri, United States

Site Status

Mallinckrodt Institute of Radiology/Washington University Medical School

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #2014.011

Identifier Type: -

Identifier Source: org_study_id