Clinical trial NCT06148285: Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
Official title: Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: LCMC Health
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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)

Primary outcomes:
measure: Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)
timeFrame: 2 weeks
measure: Feasibility outcome; proportion of patients who complete HBOT sessions
timeFrame: 2 weeks
measure: Safety outcome 1; ear pain
timeFrame: 2 weeks
measure: Safety outcome 2; barotrauma
timeFrame: 2 weeks
measure: Safety outcome 3; any other serious adverse event
timeFrame: 2 weeks
Secondary outcomes:
measure: Per-protocol analysis; change in total and subcomponents of functional independence
timeFrame: 2 weeks
measure: Adjusted HBOT treatment effect
timeFrame: 2 weeks
measure: Sub group analyses to evaluate heterogeneity of treatment effect
timeFrame: 2 weeks
measure: Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death
timeFrame: 90 days
measure: Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale
timeFrame: 90 days
measure: Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death
timeFrame: 90 days
measure: Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale
timeFrame: 90 days
measure: Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome
timeFrame: 90 days
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Touro Infirmary New Orleans
state: Louisiana
Study officials:
References: