Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression
Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study
Assaf-Harofeh Medical Center
142 participants
Nov 8, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Age between 50 -85
- Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
- Treated or being treated by antidepressants for at least 3 months
- Diagnosis of PSD based on HDRS-17 score of 17 and above.
- Stable psychological and pharmacological treatment for more than three months prior to inclusion.
- Subject willing and able to read, understand and sign an informed consent.
Exclusion Criteria18
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
- Diagnosis of aphasia or major cognitive decline
- History of Deep brain stimulation (DBS)
- History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
- Active malignancy
- Substance use at baseline.
- 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
- Serious suicidal ideation
- Renal or liver insufficiency, electrolyte imbalances
- Chronic heart failure with ejection fraction of 30 or less
- HBOT for any reason prior to study enrolment
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- An inability to perform an awake brain MRI
- No evidence of vascular related lesions in the brain MRI
- Active smoking
- Participation in another study
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07423273