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Completed

NCT Number: NCT04297358

Hyperbaric Oxygen in Patients Who Had a Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hyperbaric Oxygen Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Druckkammerzentrum Basel

Basel, 4057, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric oxygen

Drug

40 consecutive (5/7) sessions of hyperbaric oxygen

Primary outcomes

  1. Change in National Institutes of Health Stroke Scale (NIHSS score)

    Time frame: Change from Baseline NIHSS Score at 3 months

    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).

  2. Change in Rivermead mobility index (RMI) at 2 weeks

    Time frame: Change from Baseline 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.

  3. Change in Rivermead mobility index (RMI) at 4 weeks

    Time frame: Change from Baseline 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.

  4. Change in Rivermead mobility index (RMI) at 6 weeks

    Time frame: Change from Baseline 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.

  5. Change in Rivermead mobility index (RMI) at 8 weeks

    Time frame: Change from Baseline 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.

  6. Change in Rivermead mobility index (RMI) at 1 month

    Time frame: Change from Baseline 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.

  7. Change in Rivermead mobility index (RMI) at 3 months

    Time frame: Change from Baseline 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 outcomes

  1. Tympanic damage

    Time frame: From date of Start of HBOT until the date of End of HBOT

    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.

  2. Change in Visual Acuity

    Time frame: Change from Baseline Visual Acuity at 3 months

    Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed.

Sponsors and collaborators

Lead sponsor

Hyperbaric Center Basel

Other

Registry information

Official study title

Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study

Acronym: HOST

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2020
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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