HOST: Hyperbaric Oxygen in Patients Who Had a Stroke
Study Details
Study Description
Brief Summary
Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 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 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.
- 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 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 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 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.
Secondary Outcome Measures
- 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.
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Druckkammerzentrum Basel | Basel | Switzerland | 4057 |
Sponsors and Collaborators
- Hyperbaric Center Basel
Investigators
- Principal Investigator: Marco Gelsomino, med pract, Druckkammerzentrum Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-02131