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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

July 5, 2007
May 30, 2013
July 2007
September 2012   (final data collection date for primary outcome measure)
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 ]
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. ]
Complete list of historical versions of study NCT00497432 on ClinicalTrials.gov Archive Site
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 ]
A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination. [ Time Frame: After twenty patients have recieved treatment. ]
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Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities
Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy

  • Neurological Impairments
  • Leukoencephalopathies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00497432
2006.028
No
John Davidson, St. Luke's Hospital, Chesterfield, Missouri
St. Luke's Hospital, Chesterfield, Missouri
Washington University School of Medicine
Principal Investigator: John D Davidson, MD St Luke's Hospital
St. Luke's Hospital, Chesterfield, Missouri
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP