Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT07423273

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Led by Assaf-Harofeh Medical Center · Updated on 2026-04-17

142

Participants Needed

1

Research Sites

368 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 85 years
  • Ischemic stroke occurred 6 months to 7 years before inclusion
  • Treated or currently being treated with antidepressants for at least 3 months
  • Diagnosis of post-stroke depression with HDRS-17 score of 17 or above
  • Stable psychological and pharmacological treatment for more than 3 months before inclusion
  • Willing and able to read, understand, and sign informed consent
Not Eligible

You will not qualify if you...

  • Unable to attend scheduled clinic visits or comply with study protocol
  • Psychiatric disorder before recent stroke, including major depression, schizophrenia, or bipolar disease
  • Aphasia or major cognitive decline
  • History of deep brain stimulation
  • History of traumatic brain injury, brain tumors, brain surgery, chronic subdural hemorrhages, or epilepsy
  • Active malignancy
  • Substance use at baseline
  • History of neurodegenerative diseases such as Alzheimer's, Parkinson's, Lewy body dementia, frontotemporal dementia, multiple sclerosis, ALS, Creutzfeld Jacob disease, multisystem atrophy, pseudobulbar palsy, corticobasal degeneration, or Wernicke Korsakoff syndrome
  • Serious suicidal ideation
  • Renal or liver insufficiency, electrolyte imbalances
  • Chronic heart failure with ejection fraction of 30 or less
  • Prior HBOT treatment
  • Chest pathology incompatible with pressure changes, including active asthma or COPD
  • Ear or sinus pathology incompatible with pressure changes (more than 3 otolaryngologist visits per year)
  • Unable to perform awake brain MRI
  • No evidence of vascular lesions on brain MRI
  • Active smoking
  • Participation in another study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Zrifin, Israel, 70300

Actively Recruiting

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Research Team

S

Shai a Efrati, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression | DecenTrialz