Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Louisiana
Touro Infirmary New Orleans
RECRUITING
New Orleans
Contact Information
Primary
Lawrence Matarutse
Lawrence.Matarutse@lcmchealth.org
504-962-6419
Backup
Sheryl Martin-Schild, MD, PhD
sheryl.martin-schild@lcmchealth.org
504-982-3278
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
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.
Sponsors
Leads: LCMC Health