Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

NCT00497432 | Completed

• 1 other identifier: 2006.028
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurological Impairments; Leukoencephalopathies

Keywords

Hyperbaric Oxygen

Outcome Measures

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.

  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.

  After twenty patients have recieved treatment.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital, Chesterfield, Missouri: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Mallinckrodt Institute of Radiology/Washington University Medical School

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Leukoencephalopathies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John D Davidson, MD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (2)