What is the mechanism of action of this treatment?

Common treatments for stroke include thrombolytics, antiplatelet agents, anticoagulants, and mechanical thrombectomy. Thrombolytics, such as tissue plasminogen activator (tPA), dissolve blood clots to restore blood flow. Antiplatelet agents and anticoagulants prevent new clots from forming. Mechanical thrombectomy physically removes clots from large arteries. Hyperbaric Oxygen Therapy (HBOT) increases oxygen availability to tissues, potentially reducing ischemic damage and promoting recovery by enhancing oxygen delivery to the brain, reducing inflammation, and supporting neuroplasticity. These treatments are crucial for stroke patients as they aim to minimize brain damage, improve functional outcomes, and enhance overall recovery.

What side effects are associated with this type of intervention?

Common treatments for stroke that aim to increase oxygen availability to tissues include Hyperbaric Oxygen Therapy (HBOT). Known side effects of HBOT can include barotrauma to the ears and sinuses, oxygen toxicity leading to seizures, and claustrophobia due to the enclosed treatment chamber. Additionally, there is a risk of temporary vision changes and, in rare cases, lung damage. It is important for patients to discuss these potential risks with their healthcare provider to determine the best course of treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for acute ischemic stroke that aim to restore blood flow and reduce ischemic damage. The primary treatment is tissue plasminogen activator (tPA), which dissolves blood clots obstructing blood flow to the brain. Mechanical thrombectomy, a procedure to physically remove clots, is also approved for certain patients. While Hyperbaric Oxygen Therapy (HBOT) is being studied for its potential to increase oxygen availability and promote recovery, it is not yet FDA-approved for stroke treatment. Current research is exploring its feasibility, safety, and efficacy in this context.

What other types of research exist?

Promising novel alternatives to HBOT for stroke patients include: 1) Neuroprotective agents such as edaravone, which has shown efficacy in reducing oxidative stress and improving outcomes in stroke patients. 2) Advanced neurorehabilitation techniques like robotic-assisted therapy and virtual reality, which enhance motor recovery and cognitive function. 3) Stem cell therapy, which is being investigated for its potential to repair and regenerate damaged brain tissue. 4) Transcranial magnetic stimulation (TMS), a non-invasive method that can improve neuroplasticity and functional recovery. These alternatives offer new avenues for enhancing stroke recovery and should be discussed with a healthcare provider.

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Hyperbaric Oxygen Therapy for Stroke

N/A

Recruiting

Research Sponsored by LCMC Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and above

Admitted to Touro Inpatient Rehab Facility

Must not have

Pre-stroke modified Rankin Scale Score >2

Pulmonary disease requiring supplemental oxygen or daily respiratory medication management (metered dose inhalers, nebulized treatment or steroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of HBOT may include worsening of neurological symptoms like seizures or bleeding in the brain. There might also be risks related to increased oxygen pressure such as ear pain or damage due to barotrauma unless preventive measures are taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am admitted to Touro Inpatient Rehab Facility.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was mostly independent before my stroke.

Select...

I need daily medication or oxygen for my lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)

Feasibility outcome; proportion of patients who complete HBOT sessions

Safety outcome 1; ear pain

+2 more

Secondary study objectives

Adjusted HBOT treatment effect

Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale

Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death

+5 more

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02363959

10%

Repeat bronchoscopy due to bleeding during biopsy

100%

80%

60%

40%

20%

Study treatment Arm

Hyperbaric Oxygen, Airway Biopsy

No Hyperbaric Oxygen, Airway Biopsy

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric Oxygen Therapy

2016

Completed Phase 4

~800

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke include thrombolytics, antiplatelet agents, anticoagulants, and mechanical thrombectomy. Thrombolytics, such as tissue plasminogen activator (tPA), dissolve blood clots to restore blood flow. Antiplatelet agents and anticoagulants prevent new clots from forming. Mechanical thrombectomy physically removes clots from large arteries. Hyperbaric Oxygen Therapy (HBOT) increases oxygen availability to tissues, potentially reducing ischemic damage and promoting recovery by enhancing oxygen delivery to the brain, reducing inflammation, and supporting neuroplasticity. These treatments are crucial for stroke patients as they aim to minimize brain damage, improve functional outcomes, and enhance overall recovery.

Hyperbaric oxygen therapy and preconditioning for ischemic and hemorrhagic stroke.Use of normobaric and hyperbaric oxygen in acute focal cerebral ischemia - a preclinical and clinical review.