StrokePhase 4HOSTNCT04297358
Hyperbaric Oxygen in Patients Who Had a Stroke
A Phase 4 study testing Hyperbaric oxygen in people with Stroke and Hyperbaric Oxygen, run by Hyperbaric Center Basel at 1 site in Switzerland.
Trial summary
Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hyperbaric Oxygen
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Dec 2017to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological issue:
- inability to understand the informed consent form
- Hemiplegia
- Hyperbaric issue:
- Claustrophobia
- inability to put on face mask
Show all 10Show fewer
- uncontrolled epilepsy
- dementia or psychological disturbance
- previous pneumothorax
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study
Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.
Read the 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.
- Conditions
- Stroke, Hyperbaric Oxygen
- Being tested
- Hyperbaric oxygen
- Keywords
- Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
40 consecutive (5/7) sessions of hyperbaric oxygen
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | 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. Receives: Drug: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline RMI at 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline Visual Acuity at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Dec 2017
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyperbaric Center Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Gelsomino, med pract, Principal investigator, Druckkammerzentrum Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297358
- Sponsor's protocol ID
- 2017-02131
- Other IDs
- 2017
- Acronym
- HOST
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study
- ClinicalTrials.gov ID
- NCT04297358
- Acronym / sponsor ID
- HOST / 2017-02131
- Conditions
- Stroke, Hyperbaric Oxygen
- Keywords
- Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hyperbaric Center BaselUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Drug: Hyperbaric oxygen40 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- Neurological issue:
- Hyperbaric issue:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen40 consecutive (5/7) sessions of hyperbaric oxygen | Drug | Stroke patients |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Tympanic damage
Time frame: From date of Start of HBOT until the date of End of HBOT
Change in Visual Acuity
Time frame: Change from Baseline Visual Acuity at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Gelsomino, med pract principal investigator
Druckkammerzentrum Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric oxygen in people with Stroke and Hyperbaric Oxygen, run by Hyperbaric Center Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institutes of Health Stroke Scale (NIHSS score) (time frame: Change from Baseline NIHSS Score at 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.