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Completed

NCT Number: NCT00497432

Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

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.

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Key information

Conditions

Neurological Impairments Brain Diseases Central Nervous System Diseases Leukoencephalopathies Nervous System Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's Hospital, Chesterfield, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.

    Time frame: After twenty patients have recieved treatment.

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Chesterfield, Missouri

Other

Collaborators

  • Washington University School of Medicine

Registry information

Official study title

Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2007
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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