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RECRUITINGINTERVENTIONAL

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age between 50 -85 2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion 3. Treated or being treated by antidepressants for at least 3 months 4. Diagnosis of PSD based on HDRS-17 score of 17 and above. 5. Stable psychological and pharmacological treatment for more than three months prior to inclusion. 6. Subject willing and able to read, understand and sign an willing to sign a consent form. Who Should NOT Join This Trial: 1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease. 3. Diagnosis of aphasia or major cognitive decline 4. History of Deep brain stimulation (DBS) 5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy 6. Active malignancy 7. Substance use at baseline. 8. 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 9. Serious suicidal ideation 10. Renal or liver insufficiency, electrolyte imbalances 11. Chronic heart failure with ejection fraction of 30 or less 12. HBOT for any reason prior to study enrolment 13. Chest pathology incompatible with pressure changes (including active asthma or COPD) 14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year) 15. An inability to perform an awake brain MRI 16. No evidence of vascular related lesions in the brain MRI 17. Active smoking 18. Participation in another study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age between 50 -85 2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion 3. Treated or being treated by antidepressants for at least 3 months 4. Diagnosis of PSD based on HDRS-17 score of 17 and above. 5. Stable psychological and pharmacological treatment for more than three months prior to inclusion. 6. Subject willing and able to read, understand and sign an informed consent. Exclusion Criteria: 1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease. 3. Diagnosis of aphasia or major cognitive decline 4. History of Deep brain stimulation (DBS) 5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy 6. Active malignancy 7. Substance use at baseline. 8. 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 9. Serious suicidal ideation 10. Renal or liver insufficiency, electrolyte imbalances 11. Chronic heart failure with ejection fraction of 30 or less 12. HBOT for any reason prior to study enrolment 13. Chest pathology incompatible with pressure changes (including active asthma or COPD) 14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year) 15. An inability to perform an awake brain MRI 16. No evidence of vascular related lesions in the brain MRI 17. Active smoking 18. Participation in another study

Treatments Being Tested

DEVICE

hyperbaric oxygen therapy

The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.

Locations (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel