Hyperbaric Oxygen Therapy for Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: LCMC Health
Must not be taking: Respiratory medications
Disqualifiers: Hemorrhagic transformation, Receptive aphasia, Seizures, Pulmonary disease, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial will test if breathing pure oxygen in a pressurized chamber helps stroke patients recover better by improving blood flow and repairing brain cells. It focuses on patients in rehab after a stroke to see if this treatment can safely enhance their recovery. Hyperbaric oxygen therapy (HBO) has been shown to facilitate oxygen delivery and increase oxygen supply, with accumulated evidence demonstrating its potential benefits for stroke recovery.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a pulmonary disease requiring daily respiratory medication, you may not be eligible to participate.
What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for stroke?
Is Hyperbaric Oxygen Therapy generally safe for humans?
How is hyperbaric oxygen therapy different from other stroke treatments?
Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing 100% oxygen in a pressurized chamber, which increases oxygen levels in the blood and helps deliver more oxygen to the brain tissue. This can potentially reduce brain damage and swelling after a stroke, unlike standard treatments that primarily focus on restoring blood flow.1241112
Eligibility Criteria
This trial is for adults over 18 who've had an ischemic stroke within the last 7-30 days, confirmed by imaging, and are admitted to Touro Inpatient Rehab. It's not for those with severe pre-stroke disabilities, certain types of hemorrhage or brain swelling after stroke, communication issues that prevent understanding safety instructions, recent uncontrolled seizures, or chronic lung diseases needing daily medication.Inclusion Criteria
I had a stroke between 7 to 30 days ago.
Ischemic stroke proven on neuroimaging
I am 18 years old or older.
See 1 more
Exclusion Criteria
I was mostly independent before my stroke.
I've had seizures that needed different treatment in the last 3 months.
I need daily medication or oxygen for my lung condition.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive HBOT or sham treatment for 60 minutes, 10 sessions over two weeks
2 weeks
10 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
90 days
Treatment Details
Interventions
- Hyperbaric Oxygen Therapy (Procedure)
Trial OverviewThe study tests Hyperbaric Oxygen Therapy (HBOT) during inpatient rehab after an acute ischemic stroke. It looks at whether HBOT can be done without interrupting standard therapy sessions and if it leads to fewer neurological problems while improving communication skills, daily activities functioning, and mobility.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 100% oxygen under 2.0ATAExperimental Treatment1 Intervention
The first intervention arm consists of ischemic stroke patients who would undergo HBOT at 2.0 ATA with 100% oxygenation for 60 minutes x10 treatments (Monday-Friday of two sequential weeks).
Group II: 21% oxygen under 2.0ATAActive Control1 Intervention
The second intervention arm would consist of ischemic stroke patients undergoing HBOT at 2.0 ATA with 21% oxygen (room air) for 60 minutes x10 treatments (Monday-Friday of two sequential weeks).
Group III: 21% oxygen under 1.14ATAPlacebo Group1 Intervention
For sham-control; ischemic stroke patients will undergo placement in the hyperbaric oxygen chamber for the same duration of time (60 minutes x10 treatments, Monday-Friday of two sequential weeks) and pressure maintained at 1.14 ATA with 21% oxygen (room air), a non-therapeutic dose of HBOT that sufficiently increases pressure to simulate ear popping, hence maintaining participants blinded to the intervention / sham.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Touro Infirmary New OrleansNew Orleans, LA
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Who Is Running the Clinical Trial?
LCMC HealthLead Sponsor
References
Hyperbaric oxygen therapy for acute ischaemic stroke. [2022]Most cases of stroke are caused by impairment of blood flow to the brain (ischaemia) which results in a reduction in oxygen available and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing the oxygen available, and it may further improve outcome by reducing brain swelling. Some centres are using HBOT routinely to treat stroke.
Hyperbaric Oxygen and Outcomes Following the Brain Injury: A Systematic Review. [2023]Hyperbaric oxygen therapy (HBO2) aims to address ischemia resulting from brain injury by subjecting patients to an atmosphere that dramatically raises the concentration of inspired oxygen (100% O2 at greater than 1 ATA). This results in elevated levels of oxygen in the plasma, which in turn boosts the delivery of oxygen for diffusion to the brain tissue.
Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. [2019]Hyperbaric oxygen therapy (HBO) has promise as a treatment for acute stroke. This study was conducted to evaluate the efficacy, safety, and feasibility of using HBO in acute ischemic stroke.
Management of haemorrhagic stroke with hyperbaric oxygen therapy--a case report. [2007]Hyperbaric oxygen therapy (HBOT) has been used in the treatment of cerebral ischaemia with positive effects on tissue oxygenation. We present a case of haemorrhagic stroke treated successfully with HBOT and review the literature on its role in cerebrovascular disease.
Hyperbaric oxygen therapy of cerebral ischemia. [2022]Hyperbaric oxygen (HBO) therapy of cerebral ischemia has been evaluated in a number of human and animal studies; however, there is presently no consensus on its efficacy.
A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]To describe the distribution and occurrence of adverse events recorded during hyperbaric oxygen (HBO) therapy from 2012 to 2015. In this analysis, events are defined as otic/sinus barotrauma, confinement anxiety, hypoglycemia, oxygen toxicity, pneumothorax, seizure, and shortness of breath.
Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]Hyperbaric oxygen (HBO2) therapy is a safe and well-tolerated treatment modality. Seizures, one of the most severe central nervous system side effects of HBO2 therapy, can occur. Episodes of seizures during HBO2 therapy have not yet been reported in countries such as Korea, where hyperbaric medicine is still in the developmental stage.
Oxygen toxicity seizures: 20 years' experience from a single hyperbaric unit. [2018]Oxygen toxicity seizures (OTS) are a known complication of hyperbaric oxygen therapy (HBOT). The incidence of OTS has been variously reported and appears to be related to the duration and pressure of exposure in addition to individual susceptibility factors.
Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence. [2022]To provide information about hyperbaric oxygen therapy (HBOT), its mechanisms, indications and safe applications based on clinical evidence.
Seizure incidence by treatment pressure in patients undergoing hyperbaric oxygen therapy. [2015]Hyperbaric oxygen (HBO2) therapy uses different maximum treatment pressures. A side effect of HBO2 is oxygen toxicity seizure. The purpose of this study was to determine the overall incidence of oxygen toxicity seizure and assess risk at different treatment pressures.
Hyperbaric oxygen therapy. [2017]Hyperbaric oxygen (HBO) therapy is defined as treatment in which a patient breathes 100% oxygen while under a pressure greater than one atmosphere. The efficacy of hyperbaric therapy is based on a reduction in volume of gas-filled spaces; and an elevation of the partial pressure of oxygen resulting in hyperoxygenation of perfused tissues. Multiple animal studies, clinical trials, and extensive clinical experience have produced a set of 12 indications for which HBO therapy may be beneficial.
Improvement of clinical outcome and cerebral perfusion in a patient of atherosclerotic cerebral infarction after repetitive hyperbaric oxygen treatment--a case report and literature review. [2011]This is a case report of hyperbaric oxygen therapy (HBO2T) for ischemic stroke. HBO2T should be the potential or additional treatment (with thrombolytic therapy) for ischemic stroke according to the preclinical and clinical studies. Hereby, we present a 56-year-old Chinese man with vascular risk factors. He had an acute ischemic stroke on the left corona radiata, with right hemiparesis and dysarthria resulting from atherosclerosis. The patient could not get thrombolytic treatment because the time to ER was in excess of five hours. He experienced great improvement after the general course of HBO2T; this was evaluated with standard rating scales for stroke research and cerebral perfusion images, including brain-computed tomography perfusion (CTP) and single-photon emission computed tomography (SPECT). Although few clinical trials showed a negative result, we suggest that further trials on HBO2T are still needed. Meanwhile, we emphasize the importance of HBO2T protocol and the selection of a suitable patient, which may influence the outcome.