Recruiting

Hyperbaric Oxygen Therapy

Sponsor:

LCMC Health

Code:

NCT06148285

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen Therapy

Study Details

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

Study ID

NCT06148285

Start date

May 24, 2022

Status verified date

Nov, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Primary outcome measure

  • Efficacy outcome; change in total and subcomponents of functional independence measure (FIM) [ Time Frame: 2 weeks ]
  • Feasibility outcome; proportion of patients who complete HBOT sessions [ Time Frame: 2 weeks ]
  • Safety outcome 1; ear pain [ Time Frame: 2 weeks ]
  • Safety outcome 2; barotrauma [ Time Frame: 2 weeks ]
  • Safety outcome 3; any other serious adverse event [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Lawrence Matarutse

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

Sheryl Martin-Schild, MD, PhD

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

Locations

Touro Infirmary New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Lawrence Matarutse

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

More Information

Sponsor

LCMC Health

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LCMC Health on 2023-11-28.