NCT06148285 · LCMC Health
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
What this study is about
This study will critically examine the feasibility, safety and effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy
Primary outcome measures
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.
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.
Safety outcome 1; ear pain
Time frame: 2 weeks
Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.
Safety outcome 2; barotrauma
Time frame: 2 weeks
Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- New Orleans, Louisiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2023 · Source of record for eligibility and locations