Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

Leukoencephalopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497432
• Other study ID #: 2006.028
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: May 30, 2013
• Start date: July 2007
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: St. Luke's Hospital, Chesterfield, Missouri
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukoencephalopathies
• Neurological Impairments

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Mallinckrodt Institute of Radiology/Washington University Medical School	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Hospital, Chesterfield, Missouri	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.		After twenty patients have recieved treatment.	No