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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
LCMC Health
Study ID
NCT06148285
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperbaric Oxygen Therapy — DEVICE
    Hyperbaric Oxygen Therapy

Study Details

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.

Key Dates

Start date
May 24, 2022
Status verified
Nov 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Efficacy outcome; change in total and subcomponents of functional independence measure (FIM) [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Touro Infirmary New OrleansNew OrleansLouisiana70112
Lawrence Matarutse
[email protected]
504-962-6419

Find similar trials in New Orleans, LA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Touro Infirmary New Orleans· New Orleans, LA

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