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

October 25, 2017 updated by: John Davidson, St. Luke's Hospital, Chesterfield, Missouri

The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63017
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Mallinckrodt Institute of Radiology/Washington University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric oxygen treatment
HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Chesterfield, Missouri

Collaborators

Washington University School of Medicine

Investigators

  • Principal Investigator: John D. Davidson, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 25, 2017

Study Completion (Actual)

October 25, 2017

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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