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

NCT06148285 | Recruiting DMC FDA Device

• 1 other identifier: Pro00061930.1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Safety outcome 1; ear pain

  Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.

  2 weeks

• Safety outcome 2; barotrauma

  Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.

  2 weeks

• 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 Outcomes (8)

• Per-protocol analysis; change in total and subcomponents of functional independence

  2 weeks

• Adjusted HBOT treatment effect

  2 weeks

• Sub group analyses to evaluate heterogeneity of treatment effect

  2 weeks

• Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death

  90 days

• Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale

  90 days

Study Arms (3)

100% oxygen under 2.0ATA

EXPERIMENTAL

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).

Device: Hyperbaric Oxygen Therapy

21% oxygen under 2.0ATA

ACTIVE COMPARATOR

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).

Device: Hyperbaric Oxygen Therapy

21% oxygen under 1.14ATA

SHAM COMPARATOR

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.

Device: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy DEVICE

Hyperbaric Oxygen Therapy

100% oxygen under 2.0ATA; 21% oxygen under 1.14ATA; 21% oxygen under 2.0ATA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LCMC Health: lead

Study Sites (1)

Touro Infirmary New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Lawrence Matarutse

CONTACT

504-962-6419; Lawrence.Matarutse@lcmchealth.org

Sheryl Martin-Schild, MD, PhD

CONTACT

504-982-3278; sheryl.martin-schild@lcmchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Neurology & Stroke

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: November 28, 2023
• Study Start: May 24, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests may be submitted 12 months after publication of all planned manuscripts. Data will be made accessible for up to 12 months. Extensions may be considered on a case-by-case basis.
• Access Criteria: Only fully de-identified data elements will be shared with qualified investigators, for use of personal (non-commercial) research. Data will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)