RecruitingNot Applicable

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Israel142 participantsStarted 2023-11-08

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PSD symptoms

Timeframe: Change from Baseline immediately after the intervention

Trial details

NCT IDNCT07423273

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2030-12-01

Contact for this trial

Shai a Efrati, MD

972549212866 efratishai@outlook.com

View on ClinicalTrials.gov More Post Stroke Depression trials