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NCT Number: NCT06148285

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

This study will critically examine the feasibility, safety and efficacy of HBOT during inpatient rehabilitation (IPR) after acute ischemic stroke measured by non-disruption of 3 hours of daily therapy, frequency of neurological deterioration or complications (seizure, hemorrhage, brain edema), and functional communication, activities of daily living (ADLs) and mobility.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Touro Infirmary New Orleans

New Orleans, Louisiana, 70112, United States

Location status: Recruiting

Location contact

Lawrence Matarutse

CONTACT

[email protected]

504-962-6419

About this study

Preclinical studies support that HBOT augments several adaptive mechanisms following ischemic stroke, including neuroplasticity, cerebral angiogenesis, and regeneration of nerve fibers. The earlier the treatment, the greater potential for a therapeutic effect. However, logistical issues and safety concerns have prevented application of HBOT in the hyperacute window, particularly when coupled with recanalization therapy as the risk of hemorrhagic conversion is highest, monitoring intervals are short, and the natural history is being altered by another treatment. By enrolling patients who are in the subacute phase of stroke who are admitted to an inpatient rehab facility, the risk of HBOT is lower, monitoring intervals are longer, and the selected population has newly acquired and targetable stroke-related disability. Further, the patients are in a supervised setting and available for daily one-hour treatments without disrupting their intensive multidisciplinary rehab plan thereby minimizing nonadherence to daily treatments. Neuroimaging supports that injured, but not dead, brain cells can persist for months after an ischemic event. Hypoxia mediates cellular activity and death through multiple mechanisms. Ongoing decrease in oxygenation to the damaged area due to impaired blood flow works against cellular repair, recovery, and development of new synaptic connections. Increasing oxygen availability has been considered as an obvious treatment for stroke. HBOT has the potential to facilitate the recovery of injured or inactive neurons through increased blood flow and oxygen delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and above
  • Ischemic stroke proven on neuroimaging
  • Within 7-30 days post-stroke on day 1 of treatment
  • Admitted to Touro Inpatient Rehab Facility

Exclusion criteria

  • Pre-stroke modified Rankin Scale Score >2
  • Parenchymal hemorrhagic transformation (PH1 or PH2)
  • Receptive aphasia such that recommendations for preventative measures to mitigate barotrauma cannot be followed
  • History of recurrent and unprovoked seizures requiring a change in management in the last 3 months to control seizures
  • Pulmonary disease requiring supplemental oxygen or daily respiratory medication management (metered dose inhalers, nebulized treatment or steroids)

Treatment and study plan

hyperbaric oxygen therapy

Device

Hyperbaric Oxygen Therapy

Primary outcomes

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

    Time frame: 2 weeks

    Difference in the total, motor, and cognitive functional independence measure (FIM) scores between the three arms at the end of respective treatment blocks (2 - week period). Additional analyses for change in the FIM score will also be conducted.

  2. Feasibility outcome; proportion of patients who complete HBOT sessions

    Time frame: 2 weeks

    At least 80% of enrolled patients will be able complete all planned HBOT sessions. HBOT will not directly influence a reduction in quantity or quality of prescribed standard of care rehabilitative therapy.

  3. Safety outcome 1; ear pain

    Time frame: 2 weeks

    Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.

  4. Safety outcome 2; barotrauma

    Time frame: 2 weeks

    Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.

  5. Safety outcome 3; any other serious adverse event

    Time frame: 2 weeks

    any of the following absolute difference (AD) vs. control group ≤ 20%: neurological worsening (increase in NIHSS at least 4 points), symptomatic intracranial hemorrhage (parenchymal hemorrhage with neurological worsening), status epilepticus, pulmonary dysfunction (Defined as: respiratory sx requiring supplemental O2, breathing treatment, or evident of pneumothorax or pneumonia on chest imaging performed to evaluate respiratory sx), or death attributed to intervention.

Secondary outcomes

  1. Per-protocol analysis; change in total and subcomponents of functional independence

    Time frame: 2 weeks

    Per-protocol analysis comparing total and sub-component FIM scores among HBOT treated and non-HBOT treated patients who completed all HBOT treatment as per the study protocol.

    Comparison of FIM sub-scores on the FIM functional and cognitive sub-scales. Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via generalized linear modeling Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)

  2. Adjusted HBOT treatment effect

    Time frame: 2 weeks

    Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via generalized linear modeling

  3. Sub group analyses to evaluate heterogeneity of treatment effect

    Time frame: 2 weeks

    Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)

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

    Time frame: 90 days

    We will compare the proportions of HBOT and non-HBOT treated patients who achieve a 90-day mRS of 0 - 2 (good functional outcome) vs. 3 - 6 (Significant to severe disability or death - SSD) based on intent to treat populations. Additional analyses for the 90-day mRS would include Per-protocol analysis comparing 90-day mRS among HBOT treated and non-HBOT treated patients who completed all HBOT treatments as per the study protocol.

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

    Time frame: 90 days

    Ordinal shift in 90-Day mRS across the full scale of mRS for HBOT treated patients vs. non-HBOT treated patients - based on intent to treat and per protocol populations.

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

    Time frame: 90 days

    Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via logistic regression - based on intent to treat and per protocol populations.

  7. Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale

    Time frame: 90 days

    Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via ordinal regression models for proportional differences between treated and non-treated patients - based on intent to treat and per protocol populations.

  8. Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome

    Time frame: 90 days

    Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)

Study contacts

Contact information is provided by the study sponsor or research team.

Lawrence Matarutse

CONTACT

[email protected]

504-962-6419

Sheryl Martin-Schild, MD, PhD

CONTACT

[email protected]

504-982-3278

Sponsors and collaborators

Lead sponsor

LCMC Health

Other

Registry information

Official study title

Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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