Hyperbaric Oxygen in Patients Who Had a Stroke

Study Overview
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Brief Summary
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Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.

Detailed Description
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10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.

Official Title
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Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study

Conditions
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Stroke, Hyperbaric Oxygen

Intervention / Treatment
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* Drug: Hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI Informed consent Exclusion Criteria: Neurological issue: inability to understand the informed consent form Hemiplegia Hyperbaric issue: Claustrophobia inability to put on face mask uncontrolled epilepsy dementia or psychological disturbance previous pneumothorax pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke patients<br>40 consecutive sessions of hyperbaric oxygen will be administered at a pressure of 2 absolute atmosphere (ATA) to 10 patients. If there are drop outs, recruitment will be continued until a total of 10 patients with at least 30 sessions. | Drug: Hyperbaric oxygen<br>* 40 consecutive (5/7) sessions of hyperbaric oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in National Institutes of Health Stroke Scale (NIHSS score) | Neurological assessment before and after HBOT. Composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 (0 is better). | Change from Baseline NIHSS Score at 3 months | 
| Change in Rivermead mobility index (RMI) at 2 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 2 weeks | 
| Change in Rivermead mobility index (RMI) at 4 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 4 weeks | 
| Change in Rivermead mobility index (RMI) at 6 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 6 weeks | 
| Change in Rivermead mobility index (RMI) at 8 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 8 weeks | 
| Change in Rivermead mobility index (RMI) at 1 month | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 1 month | 
| Change in Rivermead mobility index (RMI) at 3 months | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanic damage | Digital photography before and after each daily HBOT session, that means before and after each compression/decompression in the hyperbaric chamber, to detect any ear lesion. | From date of Start of HBOT until the date of End of HBOT | 
| Change in Visual Acuity | Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed. | Change from Baseline Visual Acuity at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective