Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Post Stroke Depression

In brief

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.

Key facts

Study ID

NCT07423273

Run by

Assaf-Harofeh Medical Center

People needed

142

Starts

2023-11-08

Expected to finish

2030-12-01

Last updated by the study team

2026-04-17

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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