Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)

Acute Ischemic Stroke Clinical Trial

Official title:

Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148285
• Other study ID #: Pro00061930.1
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: LCMC Health
• Contact: Lawrence Matarutse
• Phone: 504-962-6419
• Email: Lawrence.Matarutse[@]lcmchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy

Locations

Country	Name	City	State
United States	Touro Infirmary New Orleans	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
LCMC Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)	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.	2 weeks
Primary	Feasibility outcome; proportion of patients who complete HBOT sessions	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.	2 weeks
Primary	Safety outcome 1; ear pain	Mild to moderate ear pain: absolute difference (AD) vs. control group = 20%.	2 weeks
Primary	Safety outcome 2; barotrauma	Barotrauma as diagnosed by clinical exam: AD vs. control group = 10%.	2 weeks
Primary	Safety outcome 3; any other serious adverse event	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.	2 weeks
Secondary	Per-protocol analysis; change in total and subcomponents of functional independence	Per-protocol analysis comparing total and sub-component FIM scores among HBOT treated and non-HBOT treated patients who completed all HBOT treatment as per the study protocol.; Comparison of FIM sub-scores on the FIM functional and cognitive sub-scales. Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via generalized linear modeling Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)	2 weeks
Secondary	Adjusted HBOT treatment effect	Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via generalized linear modeling	2 weeks
Secondary	Sub group analyses to evaluate heterogeneity of treatment effect	Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)	2 weeks
Secondary	Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death	We will compare the proportions of HBOT and non-HBOT treated patients who achieve a 90-day mRS of 0 - 2 (good functional outcome) vs. 3 - 6 (Significant to severe disability or death - SSD) based on intent to treat populations. Additional analyses for the 90-day mRS would include Per-protocol analysis comparing 90-day mRS among HBOT treated and non-HBOT treated patients who completed all HBOT treatments as per the study protocol.	90 days
Secondary	Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale	Ordinal shift in 90-Day mRS across the full scale of mRS for HBOT treated patients vs. non-HBOT treated patients - based on intent to treat and per protocol populations.	90 days
Secondary	Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death	Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via logistic regression - based on intent to treat and per protocol populations.	90 days
Secondary	Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale	Adjusted estimates of effect of HBOT treatment after controlling for stroke severity (NIHSS), age, pre-morbid mRS evaluated via ordinal regression models for proportional differences between treated and non-treated patients - based on intent to treat and per protocol populations.	90 days
Secondary	Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome	Sub-group analyses for age, sex, race, stroke severity (NIHSS), stroke etiology (TOAST criteria), cortical vs. sub-cortical strokes, pre-morbid disability (pre-morbid mRS)	90 days