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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial will examine if HBOT is safe and effective for stroke recovery, looking at daily therapy, neurological deterioration, communication, ADLs and mobility.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
0%
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

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.

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Who is running the clinical trial?

LCMC HealthLead Sponsor
3 Previous Clinical Trials
110 Total Patients Enrolled
~65 spots leftby Dec 2026
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