Clinical trial NCT00497432: Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities
Official title: Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Impairments
Leukoencephalopathies
Keywords: Hyperbaric Oxygen
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2007-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: After thirty patients have completed treatment.
Secondary outcomes:
measure: A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.
timeFrame: After twenty patients have recieved treatment.
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Mallinckrodt Institute of Radiology/Washington University Medical School
state: Missouri
Study officials:
affiliation: St. Luke's Hospital
name: John D Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: