Hyperbaric Oxygen in Patients Who Had a Stroke

Phase 4

Completed

• Conditions: Hyperbaric Oxygen; Stroke
• Interventions: Drug: Hyperbaric oxygen

• Registration Number: NCT04297358
• Lead Sponsor: Hyperbaric Center Basel

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.

Study Timeline

• Study Start: 2017-12-20
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stroke patients	Hyperbaric oxygen	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.

Primary Outcome Measures

Name	Time	Method
Change in Rivermead mobility index (RMI) at 6 weeks	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.
Change in Rivermead mobility index (RMI) at 1 month	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.
Change in National Institutes of Health Stroke Scale (NIHSS score)	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).
Change in Rivermead mobility index (RMI) at 3 months	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.
Change in Rivermead mobility index (RMI) at 2 weeks	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.
Change in Rivermead mobility index (RMI) at 8 weeks	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.
Change in Rivermead mobility index (RMI) at 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity	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.
Tympanic damage	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.

Trial Locations

Locations (1)

Druckkammerzentrum Basel; 🇨🇭 Basel, Switzerland