Neurological ImpairmentsNCT00497432
Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities
An observational study of Neurological Impairments and Leukoencephalopathies, run by St. Luke's Hospital, Chesterfield, Missouri at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neurological Impairments, Leukoencephalopathies
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Luke's Hospital
Chesterfield, Missouri, 63017
Mallinckrodt Institute of Radiology/Washington University Medical School
St Louis, Missouri, 63110
About this study
Official title: Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits
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.
Read the 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.
- Conditions
- Neurological Impairments, Leukoencephalopathies
- Keywords
- Hyperbaric Oxygen
- Medical subject headings
- Leukoencephalopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After twenty patients have recieved treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, John Davidson, St. Luke's Hospital, Chesterfield, Missouri
- Investigators
- John D Davidson, MD, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497432
- Sponsor's protocol ID
- 2006.028
- Status last verified
- May 2013
- First submitted
- 5 Jul 2007
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Treatment In Patients With White Matter Hyperintensities On Magnetic Resonance Imaging and Neurologic Deficits
- ClinicalTrials.gov ID
- NCT00497432
- Acronym / sponsor ID
- 2006.028
- Conditions
- Neurological Impairments, Leukoencephalopathies
- Keywords
- Hyperbaric Oxygen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Jul 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurological Symptom or deficits who demonstrate evidence of small vessel disease of the brain by leukoencephalopathy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Time frame: After thirty patients have completed treatment.
1 secondary outcome
A qualitative evaluation will be scored as positive or negative. Twenty patients will allow this determination.
Time frame: After twenty patients have recieved treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
Related trials for Neurological Impairments
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Davidson, MD principal investigator
St. Luke's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Impairments and Leukoencephalopathies, run by St. Luke's Hospital, Chesterfield, Missouri at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.