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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

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I am 18 years old or older.

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I am admitted to Touro Inpatient Rehab Facility.

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

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%

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

~720

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

LCMC HealthLead Sponsor

3 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this study recruited thus far?

"Indeed, clinicaltrials.gov shows that this medical trial is still open to enrolment and has been live since May 24th 2022. The latest update was posted on November 19th 2023 and 120 participants are currently needed at a single site."

Answered by AI

Is the recruitment period for this research endeavor currently accepting volunteers?

"According to clinicaltrials.gov, this medical study which commenced on May 24th 2022 is currently searching for participants. The latest update was provided on November 19th 2023."

Answered by AI

What are the main goals of this research endeavor?

"This 2-week clinical trial is aimed at evaluating the safety of a specific treatment in regard to ear pain. The secondary objectives include sub-group analyses examining heterogeneity of treatment effects, shift in 90-day mRS scores for hyperbaric oxygen therapy (HBOT) patients versus non HBOT patients based on intent to treat and per protocol populations, as well as adjusted estimates of effect after controlling for stroke severity, age, pre-morbid modified Rankin Scale score via logistic regression."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)

Sheryl Martin-Schild 2022. "Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148285.

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