Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities
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Purpose:
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.
Interventions:
Hyperbaric oxygen
Treatment with oxygen under elevated atmospheric pressure
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Location(s):
St. Louis, MO
USA
Year Started:
2007
Design:
Interventional, Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study.
Inclusion Criteria
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; stroke within previous six months; 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 migraines; treatment with psychotropic drugs or L-dopa within 3 months prior to enrollment.
Patient Involvement:
Patients will have baseline MRI and two others during treatment. Consecutively enrolled patients will be assigned to hyperbaric oxygen or hyperbaric air by random number. Patients will receive 10 treatments. All patients who receive placebo will be offered treatment with hyperbaric oxygen.
Primary Outcome:
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.
Secondary Outcome:
A quantitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 6/23/2009
Reviewed on: 01/05/2010.
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