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Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497432
First Posted: July 6, 2007
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
John Davidson, St. Luke's Hospital, Chesterfield, Missouri
  Purpose

The primary purpose of this study is to assess whether hyperbaric oxygen treatment improves neurological function in patients who exhibit white matter hyperintensities on MRI examination.

The secondary goal of this study is to determine if it is possible using MRI to discern a difference in perfusion of central nervous system tissue in regions of white matter hyperintensities after hyperbaric oxygen administration as compared to hyperbaric air.


Condition Phase
Neurological Impairments Leukoencephalopathies Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits

Resource links provided by NLM:


Further study details as provided by John Davidson, St. Luke's Hospital, Chesterfield, Missouri:

Primary Outcome Measures:
  • The rating scores on the physical/neurological examinations are qualitative, comparisons between the treated and the placebo groups must be analyzed utilizing non-parametric tests. [ Time Frame: After thirty patients have completed treatment. ]

Secondary Outcome Measures:
  • A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination. [ Time Frame: After twenty patients have recieved treatment. ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Consecutively enrolled patients will be assigned to hyperbaric oxygen or hyperbaric air by random number. Physicians supervising the hyperbaric treatments and the treating technicians, the evaluating neurologist, and the interpreter of the MRIs will be blinded regarding patient treatment status. All patients who receive placebo will be offered treatment with hyperbaric oxygen.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy
Criteria

Inclusion Criteria:

  • Over 50 years of age
  • White Matter Hyperintensities on MRI of brain
  • Two or more symptoms and/or Neurological impairments e.g. gait disturbance, dysequilibrium, decline in cognitive function, upper motor neuron deficit, dysmetria, hyper-reflex or unilateral increase in muscle tone

Exclusion Criteria:

  • Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema or bullae, claustrophobia, seizure disorder
  • Inability of the patient to tolerate pressurization e.g. eustachian tube dysfunction
  • Extreme cognitive impairment
  • Major Depression
  • Other uncontrolled co-morbidities e.g. diabetes, hypertension, thyroid disorders, carotid artery stenosis (over 70%), renal or hepatic dysfunction
  • History of brain tumor, head trauma, electroshock therapy,brain irradiation or migraine headaches
  Contacts and Locations
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): NCT00497432


Locations
United States, Missouri
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
Mallinckrodt Institute of Radiology/Washington University Medical School
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Luke's Hospital, Chesterfield, Missouri
Washington University School of Medicine
Investigators
Principal Investigator: John D Davidson, MD St. Luke's Hospital
  More Information

Responsible Party: John Davidson, Principal Investigator, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT00497432     History of Changes
Other Study ID Numbers: 2006.028
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by John Davidson, St. Luke's Hospital, Chesterfield, Missouri:
Hyperbaric Oxygen

Additional relevant MeSH terms:
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases