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

NCT ID: NCT06148285

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

Hyperbaric Oxygen Therapy

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).

Group Type ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

Hyperbaric Oxygen Therapy

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.

Group Type SHAM_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

Hyperbaric Oxygen Therapy

Interventions

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Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LCMC Health

OTHER

Sponsor Role lead

Responsible Party

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Sheryl Martin-Schild

Medical Director of Neurology & Stroke

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Touro Infirmary New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lawrence Matarutse

Role: CONTACT

[email protected]
504-962-6419

Sheryl Martin-Schild, MD, PhD

Role: CONTACT

[email protected]
504-982-3278

Facility Contacts

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Lawrence Matarutse

Role: primary

[email protected]
504-962-6419

Other Identifiers

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Pro00061930.1

Identifier Type: -

Identifier Source: org_study_id