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Hyperbaric Oxygen in Patients Who Had a Stroke (HOST)

Primary Purpose

Stroke, Hyperbaric Oxygen

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
Hyperbaric Center Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Druckkammerzentrum Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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 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 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 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 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 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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 26, 2020
Last Updated
March 1, 2023
Sponsor
Hyperbaric Center Basel
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1. Study Identification

Unique Protocol Identification Number
NCT04297358
Brief Title
Hyperbaric Oxygen in Patients Who Had a Stroke
Acronym
HOST
Official Title
Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyperbaric Center Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hyperbaric Oxygen
Keywords
Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen
Intervention Description
40 consecutive (5/7) sessions of hyperbaric oxygen
Primary Outcome Measure Information:
Title
Change in National Institutes of Health Stroke Scale (NIHSS score)
Description
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).
Time Frame
Change from Baseline NIHSS Score at 3 months
Title
Change in Rivermead mobility index (RMI) at 2 weeks
Description
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.
Time Frame
Change from Baseline RMI at 2 weeks
Title
Change in Rivermead mobility index (RMI) at 4 weeks
Description
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.
Time Frame
Change from Baseline RMI at 4 weeks
Title
Change in Rivermead mobility index (RMI) at 6 weeks
Description
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.
Time Frame
Change from Baseline RMI at 6 weeks
Title
Change in Rivermead mobility index (RMI) at 8 weeks
Description
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.
Time Frame
Change from Baseline RMI at 8 weeks
Title
Change in Rivermead mobility index (RMI) at 1 month
Description
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.
Time Frame
Change from Baseline RMI at 1 month
Title
Change in Rivermead mobility index (RMI) at 3 months
Description
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.
Time Frame
Change from Baseline RMI at 3 months
Secondary Outcome Measure Information:
Title
Tympanic damage
Description
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.
Time Frame
From date of Start of HBOT until the date of End of HBOT
Title
Change in Visual Acuity
Description
Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed.
Time Frame
Change from Baseline Visual Acuity at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Gelsomino, med pract
Organizational Affiliation
Druckkammerzentrum Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Druckkammerzentrum Basel
City
Basel
ZIP/Postal Code
4057
Country
Switzerland

12. IPD Sharing Statement

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Hyperbaric Oxygen in Patients Who Had a Stroke

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