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Sponsors and Collaborators: |
Intermountain Health Care, Inc. Deseret Foundation |
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Information provided by: | Intermountain Health Care, Inc. |
ClinicalTrials.gov Identifier: | NCT00830453 |
The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. This study will also look at the outcome of individuals with a chronic stable brain injury due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength, etc.) measures will be performed before the hyperbaric sessions, immediately following them, and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
Condition | Intervention | Phase |
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Brain Injury Sequelae Stroke Anoxia Trauma |
Procedure: Hyperbaric oxygen therapy (HBO2) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury |
Estimated Enrollment: | 60 |
Study Start Date: | November 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Hyperbaric oxygen is presently being used in an attempt to improve functional outcome following a multitude of brain injuries such as stroke, anoxic brain injury, traumatic brain injury, and others. Family members of brain-injured individuals correspond via the Internet into coalitions demanding that their loved ones receive hyperbaric oxygen therapy. There are anecdotal reports of benefit with hyperbaric oxygen following brain injury but there is little credible scientific evidence for efficacy of hyperbaric oxygen in brain injury. Clearly, what is needed to answer if hyperbaric oxygen improves brain injury are results from carefully designed multi-center, prospective, randomized controlled clinical trials. However, the implementation of such a Phase III clinical trial is challenging without information from Phase II trials. We propose to conduct a feasibility trial that may potentially guide a future Phase III clinical trial.
Mechanisms by which hyperbaric oxygen improves sequelae following brain injury are speculative. Hyperbaric oxygen upregulates growth factor receptor sites on human endothelium and can stimulate healing in hypoxic wounds. It is conceivable that hyperbaric oxygen exerts similar effects within damaged neuronal tissue but this information is lacking. Stem cells are present in the adult brain and there is speculation that hyperbaric oxygen may stimulate these stem cells to generate new neurons, but once again, this information is speculative.
In this Phase II feasibility prospective clinical trial, we propose to recruit and enroll 60 brain-injured subjects and expose them daily to hyperbaric oxygen at 1.5 atmospheres absolute for 60 minutes per session, for 60 sessions per subject. This research protocol is the one most commonly used by practitioners who claim benefit with hyperbaric oxygen therapy. Before and after the 60 hyperbaric oxygen sessions, and at 6 months following completion of hyperbaric oxygen, outcome measures consisting of neuropsychological testing, functional measures, health-related quality of life measures, and a neurological examination will be conducted and analyzed with the subjects serving as their own controls. Important information regarding a subsequent Phase III clinical trial, including subject recruitment, tolerance and risk of therapy, dropout rate, and potential benefit or lack of benefit with hyperbaric oxygen will be reported.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan K. Churchill, APRN-NP | (801) 408-3623 | susan.churchill@imail.org |
United States, Utah | |
LDS Hospital | Recruiting |
Salt Lake City, Utah, United States, 84143 |
Principal Investigator: | Susan K. Churchill, APRN-NP | Intermountain Health Care, Inc. |
Principal Investigator: | Lindell K. Weaver, MD | Intermountain Health Care, Inc. |
Responsible Party: | Intermountain Healthcare ( Susan K. Churchill, APRN-NP, Clinical Coordinator ) |
Study ID Numbers: | 950-352 |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830453 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain injury with sequelae from stroke, anoxia, or trauma |
Craniocerebral Trauma Cerebral Infarction Stroke Wounds and Injuries Vascular Diseases Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Cerebrovascular Disorders Anoxia Signs and Symptoms Signs and Symptoms, Respiratory Brain Injuries |
Craniocerebral Trauma Stroke Nervous System Diseases Wounds and Injuries Vascular Diseases Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Brain Diseases Cerebrovascular Disorders Anoxia Signs and Symptoms Signs and Symptoms, Respiratory Cardiovascular Diseases Brain Injuries |