Hyperbaric Oxygen Therapy for Acute Ischemic Stroke Recovery
This study is looking at Hyperbaric Oxygen Therapy (HBOT) to help people recover after an acute ischemic stroke. HBOT involves breathing pure oxygen in a special pressurized room. Researchers want to see if HBOT is safe and effective in improving daily activities and movement for stroke survivors. They are also studying if HBOT helps new blood vessels form in the brain (angiogenesis), which can aid recovery. You might be able to join if you are 18 or older, had an ischemic stroke confirmed by imaging, and are within 7-30 days of your stroke. You also need to be admitted to Touro Inpatient Rehab Facility. The study aims to enroll 120 participants. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 120 participants.
- What's involved
- Participants will receive daily one-hour Hyperbaric Oxygen Therapy sessions. The study measures outcomes at 2 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at 2 weeks after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
At a glance
Conditions
NCT06148285
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Touro Infirmary New Orleans
New Orleans, Louisianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)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 sessions2 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 pain2 weeks
Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.
- Safety outcome 2; barotrauma2 weeks
Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.
- Safety outcome 3; any other serious adverse event2 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.