Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
Purpose
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.
Condition
- Acute Ischemic Stroke
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 100% oxygen under 2.0ATA |
The first intervention arm consists of ischemic stroke patients who would undergo HBOT at 2.0 ATA with 100% oxygenation for 60 minutes x10 treatments (Monday-Friday of two sequential weeks). |
|
|
Active Comparator 21% oxygen under 2.0ATA |
The second intervention arm would consist of ischemic stroke patients undergoing HBOT at 2.0 ATA with 21% oxygen (room air) for 60 minutes x10 treatments (Monday-Friday of two sequential weeks). |
|
|
Sham Comparator 21% oxygen under 1.14ATA |
For sham-control; ischemic stroke patients will undergo placement in the hyperbaric oxygen chamber for the same duration of time (60 minutes x10 treatments, Monday-Friday of two sequential weeks) and pressure maintained at 1.14 ATA with 21% oxygen (room air), a non-therapeutic dose of HBOT that sufficiently increases pressure to simulate ear popping, hence maintaining participants blinded to the intervention / sham. |
|
Recruiting Locations
New Orleans, Louisiana 70112
More Details
- Status
- Recruiting
- Sponsor
- LCMC Health
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.