Stroke Clinical Trial
Official title:
Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
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.
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 70 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|