Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

Completed

• Conditions: Neurological Impairments; Leukoencephalopathies

• Registration Number: NCT00497432
• Lead Sponsor: St. Luke's Hospital, Chesterfield, Missouri

Brief Summary

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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Mallinckrodt Institute of Radiology/Washington University Medical School; 🇺🇸 St. Louis, Missouri, United States

St. Luke's Hospital; 🇺🇸 Chesterfield, Missouri, United States