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.

Study Overview

• Status: Completed
• Conditions: Leukoencephalopathies; Neurological Impairments

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital
    • St. Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology/Washington University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	After thirty patients have completed treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.	After twenty patients have recieved treatment.

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Chesterfield, Missouri
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: John D Davidson, MD, St. Luke's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 5, 2007
• First Submitted That Met QC Criteria: July 5, 2007
• First Posted (Estimate): July 6, 2007

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Hyperbaric Oxygen
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies
• Other Study ID Numbers: 2006.028