Hyperbaric Oxygen in Patients Who Had a Stroke (HOST)

Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Stroke; Hyperbaric Oxygen
• Intervention / Treatment: Drug: Hyperbaric oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4057
    • Druckkammerzentrum Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke patients; 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; 40 consecutive (5/7) sessions of hyperbaric oxygen

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hyperbaric Center Basel
• Investigators: Principal Investigator: Marco Gelsomino, med pract, Druckkammerzentrum Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Hyperbaric Oxygen; Prospective; Completed Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2017-02131

Drug and device information, study documents

• 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