Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

This study has been completed.
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
John Davidson, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT00497432
First received: July 5, 2007
Last updated: May 30, 2013
Last verified: May 2013
  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 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 5, 2007
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014