Hyperbaric Oxygen Therapy for Stroke

Overseen By Lawrence Matarutse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LCMC Health

Must not be taking: Respiratory medications

Disqualifiers: Hemorrhagic transformation, Receptive aphasia, Seizures, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hyperbaric oxygen therapy (HBOT) can improve recovery after an ischemic stroke. The researchers aim to determine if breathing pure oxygen in a pressurized chamber enhances daily activities, communication, and movement without causing issues like seizures or brain swelling. Participants will be divided into groups to receive varying oxygen levels, including a placebo group with normal air, to compare effects. This trial suits individuals who have had an ischemic stroke confirmed by a brain scan and are in inpatient rehab within 7 to 30 days post-stroke. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery treatments.

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 prior data suggests that Hyperbaric Oxygen Therapy is safe for stroke patients?

Research has shown that Hyperbaric Oxygen Therapy (HBOT) is generally safe for stroke survivors. Studies found no increased risk of death in the first few months after a stroke for those receiving HBOT compared to those who do not.

In this therapy, patients breathe pure oxygen at a pressure level of 2.0 ATA. Evidence supports its safety for stroke recovery, as patients did not experience more severe issues like seizures or brain swelling than expected.

Similarly, breathing air with 21% oxygen at 2.0 ATA, akin to regular air but under higher pressure, is also considered safe. Studies suggest that this treatment is well-tolerated and does not lead to significant side effects.

Overall, both types of HBOT at 2.0 ATA are safe for stroke recovery, with no major safety concerns reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperbaric oxygen therapy (HBOT) for stroke because it offers a unique approach compared to standard treatments like clot-busting drugs and physical rehabilitation. Unlike these traditional methods, HBOT involves breathing pure oxygen in a pressurized chamber, which can enhance oxygen delivery to brain tissues and potentially reduce damage after a stroke. The treatment is thought to promote healing by increasing oxygen availability, potentially leading to faster recovery times. Furthermore, HBOT's non-invasive nature makes it an attractive option for patients who may not be eligible for more invasive procedures.

What evidence suggests that this trial's treatments could be effective for stroke?

Research suggests that hyperbaric oxygen therapy (HBOT) might aid recovery from a sudden stroke. Studies have found that HBOT can reduce brain swelling and prevent cell damage after a stroke. In this trial, one group will receive pure oxygen at a pressure of 2.0 ATA, which could support brain recovery. Another group will receive regular air with 21% oxygen at the same pressure, while a third group will receive 21% oxygen at a lower pressure of 1.14 ATA as a sham control. However, there isn't enough data yet to determine if these benefits significantly improve stroke recovery. Overall, while HBOT shows promise, more research is needed to understand its effectiveness for stroke recovery. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

I am admitted to Touro Inpatient Rehab Facility.

Ischemic stroke proven on neuroimaging

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The 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.

How Is the Trial Designed?

Group I: 100% oxygen under 2.0ATA Experimental Treatment 1 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 2.0ATA Active Control 1 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 1.14ATA Placebo Group 1 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.

Who Is Running the Clinical Trial?

LCMC Health

Lead Sponsor

Trials

4

Recruited

230+

Published Research Related to This Trial

Hyperbaric oxygen therapy (HBO2T) may serve as a potential additional treatment for ischemic stroke, particularly for patients who cannot receive thrombolytic therapy due to delays in treatment, as demonstrated in a case report of a 56-year-old man who showed significant improvement after HBO2T.

The patient's recovery was assessed using standard stroke rating scales and advanced imaging techniques, highlighting the need for further clinical trials to better understand the efficacy of HBO2T and the importance of patient selection and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chen, SY., Huang, E., Wang, V., et al.[2011]

Hyperbaric oxygen therapy (HBOT) improves wound healing by enhancing oxygenation, promoting new blood vessel formation (neovascularization), and reducing inflammation, making it a valuable adjunctive treatment for chronic wounds and infections.

Clinical evidence supports the use of HBOT in various conditions, including diabetic ulcers and chronic osteomyelitis, and it may reduce the risk of severe outcomes like amputation, although many healthcare providers are still unfamiliar with its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence. Lam, G., Fontaine, R., Ross, FL., et al.[2022]

In a study of 931 patients undergoing hyperbaric oxygen therapy, the overall incidence of oxygen toxicity seizures was found to be low, occurring in 1 in 2,121 treatments, or five per 10,000 treatments.

The risk of seizures significantly increased with higher treatment pressures, with zero seizures at 2.0 atmospheres, 15 per 10,000 at 2.4/2.5 atmospheres, and 51 per 10,000 at 2.8 atmospheres, indicating that treatment pressure should be carefully considered against potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure incidence by treatment pressure in patients undergoing hyperbaric oxygen therapy. Heyboer, M., Jennings, S., Grant, WD., et al.[2015]

Animal studies indicate that hyperbaric oxygen (HBO) therapy can reduce brain damage and improve neurological outcomes after cerebral ischemia, suggesting potential benefits in early treatment.

While early human studies hinted at positive effects of HBO therapy for stroke patients, recent randomized controlled trials have not demonstrated significant benefits, highlighting the need for larger studies and better trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy of cerebral ischemia. Helms, AK., Whelan, HT., Torbey, MT.[2022]

Hyperbaric oxygen therapy (HBOT) has shown positive effects on tissue oxygenation in cases of cerebral ischaemia, suggesting its potential benefits in treating related conditions.

A specific case of a haemorrhagic stroke successfully treated with HBOT highlights its possible role in cerebrovascular disease, warranting further investigation into its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of haemorrhagic stroke with hyperbaric oxygen therapy--a case report. Lim, J., Lim, WK., Yeo, TT., et al.[2007]

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

In a pilot study of 33 patients with acute ischemic stroke, hyperbaric oxygen therapy (HBO) was found to be safe and feasible, but it did not show any significant benefits compared to a sham treatment at 24 hours or 3 months.

At 3 months, a higher percentage of patients in the sham group had better outcomes on various stroke assessment scales compared to those receiving HBO, suggesting that HBO may not only be ineffective but could potentially be harmful in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. Rusyniak, DE., Kirk, MA., May, JD., et al.[2019]

A systematic review of three randomized controlled trials involving 106 participants found no significant difference in mortality rates at six months between patients receiving hyperbaric oxygen therapy (HBOT) and those who did not, suggesting that HBOT may not improve survival outcomes in acute ischaemic stroke.

While two specific disability scales showed some improvement with HBOT at one-year follow-up, these findings were not consistent across other measures, indicating that the overall clinical benefit of HBOT in treating acute ischaemic stroke remains unclear and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for acute ischaemic stroke. Bennett, MH., Wasiak, J., Schnabel, A., et al.[2022]

Hyperbaric oxygen (HBO) therapy involves breathing 100% oxygen at pressures greater than one atmosphere, which helps reduce gas-filled spaces and increases oxygen levels in tissues.

Research, including animal studies and clinical trials, has identified 12 specific medical conditions where HBO therapy may provide therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Fitzpatrick, DT.[2017]

In a review of 41,273 hyperbaric oxygen therapy sessions involving 3,737 patients over 20 years, the incidence of oxygen toxicity seizures (OTS) was found to be low at 0.06%, indicating that while OTS is a risk, it is relatively rare.

The study revealed that the rate of OTS increases significantly with higher pressures, particularly above 203 kPa, suggesting that pressure levels during treatment should be carefully monitored to minimize the risk of seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen toxicity seizures: 20 years' experience from a single hyperbaric unit. Banham, ND.[2018]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10837997/

Efficacy and safety of hyperbaric oxygen therapy in acute ... This study aims to evaluate the efficacy and safety of adjunctive hyperbaric oxygen therapy (HBOT) in acute ischaemic stroke (AIS) based on existing evidence.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06148285?draw=2&rank=1

Hyperbaric Oxygen Therapy in Acute Ischemic Stroke ... This study will critically examine the feasibility, safety and efficacy of HBOT during inpatient rehabilitation (IPR) after acute ischemic stroke measured ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.115.008296

Hyperbaric Oxygen Therapy for Acute Ischemic Stroke We found limited clinical data, and the evidence is insufficient to confirm that HBOT significantly affects outcomes after acute ischemic stroke.

4. journals.viamedica.pl journals.viamedica.pl/international_maritime_health/article/view/97720/75651

Results of acute cerebral infarction treatment with Hyperbaric oxygen alleviates post-stroke neuroinflammation and inhibits post-stroke cell death and necrosis reactions. It also improves ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38308217/

Efficacy and safety of hyperbaric oxygen therapy in acute ... This study aims to evaluate the efficacy and safety of adjunctive hyperbaric oxygen therapy (HBOT) in acute ischaemic stroke (AIS) based on existing evidence.

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.928802/full

The application and perspective of hyperbaric oxygen ... Hyperbaric oxygen therapy, a non-pharmacological treatment, can improve the oxygenation level at the ischemic lesions in increased dissolved oxygen and oxygen ...