Acute Ischemic Stroke Clinical Trial
Official title:
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Touro Infirmary New Orleans | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
LCMC Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy outcome; change in total and subcomponents of functional independence measure (FIM) | 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 weeks | |
Primary | Feasibility outcome; proportion of patients who complete HBOT sessions | 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. | 2 weeks | |
Primary | Safety outcome 1; ear pain | Mild to moderate ear pain: absolute difference (AD) vs. control group = 20%. | 2 weeks | |
Primary | Safety outcome 2; barotrauma | Barotrauma as diagnosed by clinical exam: AD vs. control group = 10%. | 2 weeks | |
Primary | Safety outcome 3; any other serious adverse event | 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. | 2 weeks | |
Secondary | Per-protocol analysis; change in total and subcomponents of functional independence | 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 weeks | |
Secondary | Adjusted HBOT treatment effect | Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via generalized linear modeling | 2 weeks | |
Secondary | Sub group analyses to evaluate heterogeneity of treatment effect | 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 weeks | |
Secondary | Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death | 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. | 90 days | |
Secondary | Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale | 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. | 90 days | |
Secondary | Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death | 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. | 90 days | |
Secondary | Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale | 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. | 90 days | |
Secondary | Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome | 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) | 90 days |
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