Hyperbaric Oxygen in Patients Who Had a Stroke

Stroke Clinical Trial

— HOST  

Official title:

Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297358
• Other study ID #: 2017-02131
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Hyperbaric Center Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperbaric Oxygen
• Stroke

Intervention

Drug:
• Hyperbaric oxygen
40 consecutive (5/7) sessions of hyperbaric oxygen

Locations

Country	Name	City	State
Switzerland	Druckkammerzentrum Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Hyperbaric Center Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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