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

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ClinicalTrials.gov Identifier: NCT02890888
Recruitment Status : Terminated (Depletion of Funds and Illness of principal investigator)
First Posted : September 7, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
John Davidson, St. Luke's Hospital, Chesterfield, Missouri

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

Condition or disease Intervention/treatment Phase
Cerebral Small Vessel Diseases Other: hyperbaric oxygen treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 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
Study Start Date : November 2014
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890888


Locations
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United States, Missouri
St. Luke's hospital
Chesterfield, Missouri, United States, 63017
St. Luke's Hospital
Saint Louis, Missouri, United States, 63017
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
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Principal Investigator: John D. Davidson, MD Washington University School of Medicine
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Responsible Party: John Davidson, Director, Division of Hyperbaric Medicine, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT02890888    
Other Study ID Numbers: 2014.011
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Davidson, St. Luke's Hospital, Chesterfield, Missouri:
small vessel disease of the brain
hyperbaric oxygen
functional connectivity MRI
Additional relevant MeSH terms:
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Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases