Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease

NCT ID: NCT02890888

Last Updated: 2017-10-27

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-10-25

Brief Summary

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Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.

Detailed Description

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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.

Conditions

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Cerebral Small Vessel Diseases

Keywords

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small vessel disease of the brain hyperbaric oxygen functional connectivity MRI

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

HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks

Group Type EXPERIMENTAL

hyperbaric oxygen treatment

Intervention Type OTHER

Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week

Interventions

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hyperbaric oxygen treatment

Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week

Intervention Type OTHER

Eligibility Criteria

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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%)
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

Director, Division of Hyperbaric Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D. Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

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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2014.011

Identifier Type: -

Identifier Source: org_study_id