Acute Ischemic StrokeNCT06148285
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)
A study testing Hyperbaric Oxygen Therapy in people with Acute Ischemic Stroke, run by LCMC Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Touro Infirmary New Orleans
New Orleans, Louisiana, 70112
Lawrence Matarutse, 504-962-6419, Lawrence.Matarutse@lcmchealth.org
About this study
Official title: Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
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.
Read the detailed 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
Hyperbaric Oxygen Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Safety outcome 1; ear pain
Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.
Measured: 2 weeks
Safety outcome 2; barotrauma
Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (8)
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)
Measured: 2 weeks
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
Measured: 2 weeks
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)
Measured: 2 weeks
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start24 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LCMC Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Martin-Schild, LCMC Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148285
- Sponsor's protocol ID
- Pro00061930.1
- Status last verified
- Nov 2023
- First submitted
- 22 Jul 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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. 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
- ClinicalTrials.gov ID
- NCT06148285
- Acronym / sponsor ID
- Pro00061930.1
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- LCMC HealthUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100% oxygen under 2.0ATA | Experimental | Device: Hyperbaric Oxygen TherapyThe 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). |
| 21% oxygen under 2.0ATA | Active comparator | Device: Hyperbaric Oxygen TherapyThe 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). |
| 21% oxygen under 1.14ATA | Sham comparator | Device: Hyperbaric Oxygen TherapyFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy | Device | 100% oxygen under 2.0ATA, 21% oxygen under 1.14ATA, 21% oxygen under 2.0ATA |
Primary outcome
Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)
Time frame: 2 weeks
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.
Feasibility outcome; proportion of patients who complete HBOT sessions
Time frame: 2 weeks
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.
Safety outcome 1; ear pain
Time frame: 2 weeks
Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.
Safety outcome 2; barotrauma
Time frame: 2 weeks
Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.
Safety outcome 3; any other serious adverse event
Time frame: 2 weeks
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.
8 secondary outcomes
Per-protocol analysis; change in total and subcomponents of functional independence
Time frame: 2 weeks
Adjusted HBOT treatment effect
Time frame: 2 weeks
Sub group analyses to evaluate heterogeneity of treatment effect
Time frame: 2 weeks
Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death
Time frame: 90 days
Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale
Time frame: 90 days
Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death
Time frame: 90 days
Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale
Time frame: 90 days
Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Yes. 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. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Acute Ischemic Stroke, run by LCMC Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Matarutse (504-962-6419, Lawrence.Matarutse@lcmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome; change in total and subcomponents of functional independence measure (FIM) (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.