<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232958</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #2014.011</org_study_id>
    <nct_id>NCT02232958</nct_id>
  </id_info>
  <brief_title>Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease</brief_title>
  <acronym>HBO</acronym>
  <official_title>The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's Hospital, Chesterfield, Missouri</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's Hospital, Chesterfield, Missouri</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to extend our previous work, in which we demonstrated an&#xD;
      increase in the internal and cross network connectivity of resting state neural networks in&#xD;
      patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least&#xD;
      20 more individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients without contraindications to Hyperbaric Oxygen treatment or magnetic resonance&#xD;
      imaging who exhibit white matter hyper-intensities on MRI will be recruited to have a&#xD;
      functional MRI followed by10 hyperbaric oxygen treatments at 2 ATA for one hour. These&#xD;
      treatments will be done once daily, from Monday through Friday, on 2 consecutive weeks. 4-6&#xD;
      weeks later, they have a repeat fMRI. These fMRI's will be analyzed regarding any changes in&#xD;
      the resting state connectivity of various circuits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funds depleted and Ilness of Principal Investigator&#xD;
  </why_stopped>
  <start_date type="Actual">September 16, 2014</start_date>
  <completion_date type="Actual">October 4, 2017</completion_date>
  <primary_completion_date type="Actual">May 24, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen</measure>
    <time_frame>4-6 weeks after treatment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Encephalopathy</condition>
  <condition>White Matter Hyperintensities</condition>
  <condition>Impaired Oxygen Delivery</condition>
  <arm_group>
    <arm_group_label>Hyperbaric Oxygen treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperbaric Oxygen Treatment</intervention_name>
    <description>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.</description>
    <arm_group_label>Hyperbaric Oxygen treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Over 50 years of age White Matter Hyperintensities on MRI @ or more&#xD;
        symptoms and/or neurological impairments e.g. gait disturbances,disequilibrium, decline in&#xD;
        cognitive function, upper motor neuron deficit, dysmetria, hyper-refexia or unilateral&#xD;
        increase in motor tone -&#xD;
&#xD;
        Exclusion Criteria: Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema&#xD;
        or bullae, claustrophobiia, seizure diorder Inability of the patient to tolerate&#xD;
        pressurization e.g. Eustachian tube dysfunction Stroke within the previous 6 months Extreme&#xD;
        cognitive impairment Major depression Other uncontrolled co-morbidities, e.g. diabetes,&#xD;
        hypertension, thyroid disorders, carotid artery stenosis (&gt;70%), renal or hepatic&#xD;
        dysfunction History of brain tumor, head trauma, electric shock therapy, brain irradiation&#xD;
        History of migraine headaches&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John D. Davidson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Luke's Hospital St. Louis &amp; Washington University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Luke's Hospital</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mallinckrodt Institute of Radiology/Washington University Medical School</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>October 26, 2017</last_update_submitted>
  <last_update_submitted_qc>October 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Luke's Hospital, Chesterfield, Missouri</investigator_affiliation>
    <investigator_full_name>John Davidson</investigator_full_name>
    <investigator_title>Professor of Clinical Medicine Washington University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Hyperbaric Oxygen</keyword>
  <keyword>Small Vessel Disease of the Brain</keyword>
  <keyword>Impaired Brain Circuit Connections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232958
org study id: IRB #2014.011
nct id: NCT02232958
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen
time frame: 4-6 weeks after treatment
description: 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
measure: an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen
time frame: 4-6 weeks
description: 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.
arm group label: Hyperbaric Oxygen treatment
arm group type: Experimental
description: administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks
intervention type: Other
intervention name: Hyperbaric Oxygen Treatment
description: 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.
arm group label: Hyperbaric Oxygen treatment
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: John D. Davidson, MD
role: Principal Investigator
affiliation: St. Luke's Hospital St. Louis & Washington University Medical School
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Luke's Hospital, Chesterfield, Missouri
investigator full name: John Davidson
investigator title: Professor of Clinical Medicine Washington University School of Medicine
mesh term: Brain Diseases
mesh term: Cerebral Small Vessel Diseases
sharing ipd: No