[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":48,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hyperbaric oxygen therapy (HBOT) active treatment","ACTIVE_COMPARATOR","The HBOT protocol consists of 60 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes.",[13],"Device: hyperbaric oxygen therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham hyperbaric oxygen therapy (HBOT) Sham treatment","SHAM_COMPARATOR","All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, each session includes breathing 21% oxygen by mask while in the same multiplace chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks, every 20 minutes The initial 1.2 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","hyperbaric oxygen therapy","The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes.\n\nInvestigational product:\n\nMultiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Shai a Efrati, MD","Asaf-Harofhe MC","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","972549212866","efratishai@outlook.com",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":25,"geoPoint":25,"contacts":44},"The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)","RECRUITING","Zrifin","70300","Israel","IL",[45],{"name":46,"role":33,"phone":47,"phoneExt":25,"email":35},"Shai Efrati, Prof","972-8-9779393",{"type":30,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Shay Efrati","MD","100625487","hyperbaric-oxygen-therapy-for-persistent-post-stroke-depression-100625487",false,"NCT07423273","Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression","Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study","Inclusion Criteria:\n\n1. Age between 50 -85\n2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion\n3. Treated or being treated by antidepressants for at least 3 months\n4. Diagnosis of PSD based on HDRS-17 score of 17 and above.\n5. Stable psychological and pharmacological treatment for more than three months prior to inclusion.\n6. Subject willing and able to read, understand and sign an informed consent.\n\nExclusion Criteria:\n\n1. Inability to attend scheduled clinic visits and\u002For comply with the study protocol\n2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.\n3. Diagnosis of aphasia or major cognitive decline\n4. History of Deep brain stimulation (DBS)\n5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy\n6. Active malignancy\n7. Substance use at baseline.\n8. History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome\n9. Serious suicidal ideation\n10. Renal or liver insufficiency, electrolyte imbalances\n11. Chronic heart failure with ejection fraction of 30 or less\n12. HBOT for any reason prior to study enrolment\n13. Chest pathology incompatible with pressure changes (including active asthma or COPD)\n14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)\n15. An inability to perform an awake brain MRI\n16. No evidence of vascular related lesions in the brain MRI\n17. Active smoking\n18. Participation in another study","ALL","50 Years","85 Years",{"count":62,"type":63},142,"ESTIMATED","INTERVENTIONAL",[66],"NA","The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.",[69],"Post Stroke Depression",[22],"2026-04-16",{"date":73,"type":74},"2026-04-17","ACTUAL",{"date":76,"type":74},"2023-11-08",{"date":78,"type":63},"2030-12-01",{"name":5,"class":6},1]