Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities
| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2007 | ||||
| Last Updated Date | May 30, 2013 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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. ] | ||||
| Change History | Complete list of historical versions of study NCT00497432 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination. [ Time Frame: After twenty patients have recieved treatment. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination. [ Time Frame: After twenty patients have recieved treatment. ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities | ||||
| Official Title ICMJE | Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | November 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00497432 | ||||
| Other Study ID Numbers ICMJE | 2006.028 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | John Davidson, St. Luke's Hospital, Chesterfield, Missouri | ||||
| Study Sponsor ICMJE | St. Luke's Hospital, Chesterfield, Missouri | ||||
| Collaborators ICMJE | Washington University School of Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | St. Luke's Hospital, Chesterfield, Missouri | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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