Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT04297358
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2020-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen in Patients Who Had a Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in National Institutes of Health Stroke Scale (NIHSS score)', 'timeFrame': 'Change from Baseline NIHSS Score at 3 months', 'description': "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)."}, {'measure': 'Change in Rivermead mobility index (RMI) at 2 weeks', 'timeFrame': 'Change from Baseline RMI at 2 weeks', 'description': '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.'}, {'measure': 'Change in Rivermead mobility index (RMI) at 4 weeks', 'timeFrame': 'Change from Baseline RMI at 4 weeks', 'description': '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.'}, {'measure': 'Change in Rivermead mobility index (RMI) at 6 weeks', 'timeFrame': 'Change from Baseline RMI at 6 weeks', 'description': '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.'}, {'measure': 'Change in Rivermead mobility index (RMI) at 8 weeks', 'timeFrame': 'Change from Baseline RMI at 8 weeks', 'description': '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.'}, {'measure': 'Change in Rivermead mobility index (RMI) at 1 month', 'timeFrame': 'Change from Baseline RMI at 1 month', 'description': '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.'}, {'measure': 'Change in Rivermead mobility index (RMI) at 3 months', 'timeFrame': 'Change from Baseline RMI at 3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Tympanic damage', 'timeFrame': 'From date of Start of HBOT until the date of End of HBOT', 'description': '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.'}, {'measure': 'Change in Visual Acuity', 'timeFrame': 'Change from Baseline Visual Acuity at 3 months', 'description': 'Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperbaric Oxygen', 'Completed Stroke', 'Feasibility', 'Prospective'], 'conditions': ['Stroke', 'Hyperbaric Oxygen']}, 'descriptionModule': {'briefSummary': 'Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nInformed consent\n\nExclusion Criteria:\n\n* Neurological issue:\n\n * inability to understand the informed consent form\n * Hemiplegia\n* Hyperbaric issue:\n\n * Claustrophobia\n * inability to put on face mask\n * uncontrolled epilepsy\n * dementia or psychological disturbance\n * previous pneumothorax\n * pregnancy'}, 'identificationModule': {'nctId': 'NCT04297358', 'acronym': 'HOST', 'briefTitle': 'Hyperbaric Oxygen in Patients Who Had a Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hyperbaric Center Basel'}, 'officialTitle': 'Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study', 'orgStudyIdInfo': {'id': '2017-02131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke patients', 'description': '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.', 'interventionNames': ['Drug: Hyperbaric oxygen']}], 'interventions': [{'name': 'Hyperbaric oxygen', 'type': 'DRUG', 'description': '40 consecutive (5/7) sessions of hyperbaric oxygen', 'armGroupLabels': ['Stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4057', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Druckkammerzentrum Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Marco Gelsomino, med pract', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Druckkammerzentrum Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyperbaric Center Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}