RecruitingNot ApplicableNCT07423273

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

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


Sponsor

Assaf-Harofeh Medical Center

Enrollment

142 participants

Start Date

Nov 8, 2023

Study Type

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing hyperbaric oxygen therapy — breathing pure oxygen in a pressurized chamber — as a treatment for depression that develops after a stroke. Researchers want to see if this approach can help people whose post-stroke depression has not improved enough with antidepressant medications. **You may be eligible if...** - You are between 50 and 85 years old - You had an ischemic (clot-related) stroke between 6 months and 7 years ago - You have been diagnosed with depression after your stroke, with a significant score on a depression rating scale - You have been on antidepressant medication for at least 3 months - Your mental health treatment has been stable for more than 3 months **You may NOT be eligible if...** - You had depression, schizophrenia, or bipolar disorder before your stroke - You have significant communication problems (aphasia) or major cognitive decline - You have had deep brain stimulation surgery or a traumatic brain injury - You are unable to attend clinic visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEhyperbaric 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

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NCT07423273


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