Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Oxygen Therapy.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
Overview
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.
Detailed description
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.
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]
- Feasibility outcome; proportion of patients who complete HBOT sessions [Time frame: 2 weeks]
- Safety outcome 1; ear pain [Time frame: 2 weeks]
- Safety outcome 2; barotrauma [Time frame: 2 weeks]
- Safety outcome 3; any other serious adverse event [Time frame: 2 weeks]
Secondary outcome measures (8)
- Per-protocol analysis; change in total and subcomponents of functional independence [Time frame: 2 weeks]
- Adjusted HBOT treatment effect [Time frame: 2 weeks]
- Sub group analyses to evaluate heterogeneity of treatment effect [Time frame: 2 weeks]
- Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death [Time frame: 90 days]
- Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale [Time frame: 90 days]
- Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death [Time frame: 90 days]
- Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale [Time frame: 90 days]
- Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome [Time frame: 90 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Touro Infirmary New Orleans — New Orleans
Identifiers
NCT: NCT06148285 · Pro00061930.1