Hyperbaric oxygen therapy for persistent post-stroke depression

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

This research will test whether hyperbaric oxygen therapy can reduce depressive symptoms in adults with long-standing post-stroke depression who are already on antidepressants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Assaf-Harofeh Medical Center (Government)
• Locations: 1 site (Zrifin)
• Trial ID: NCT07423273 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, sham-controlled interventional protocol using hyperbaric oxygen therapy (HBOT) based on the hyperoxic-hypoxic paradox to attempt regeneration of chronically injured brain tissue. Eligible participants are adults aged 50–85 who had an ischemic stroke 6 months to 7 years earlier and have persistent depression with HDRS-17 scores of 17 or higher while on stable antidepressant and psychological treatment. Participants receive repeated HBOT sessions at the Sagol Center and are compared with a sham hyperbaric protocol, with primary outcomes focused on changes in depressive symptoms and secondary outcomes on cognitive and functional measures. The trial aims to determine whether HBOT-induced neuroplasticity can translate into clinical improvements in persistent post-stroke depression.

Who should consider this trial

Good fit: Ideal candidates are adults 50–85 years old who had an ischemic stroke 6 months to 7 years ago, have HDRS-17 scores ≥17, and have been on stable antidepressant and psychological treatment for at least three months.

Not a fit: Patients with pre-stroke major psychiatric disorders, major cognitive decline or aphasia, epilepsy, recent brain surgery or trauma, active malignancy, substance use at baseline, or inability to attend sessions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HBOT could reduce depressive symptoms and improve cognitive and functional recovery by promoting brain repair and neuroplasticity.

How similar studies have performed: Cumulative clinical reports and some controlled studies suggest HBOT can induce neuroplasticity and functional gains after chronic stroke, but robust double-blind randomized evidence specifically for persistent post‑stroke depression remains limited.

Eligibility criteria

Inclusion Criteria:

1. Age between 50 -85
2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
3. Treated or being treated by antidepressants for at least 3 months
4. Diagnosis of PSD based on HDRS-17 score of 17 and above.
5. Stable psychological and pharmacological treatment for more than three months prior to inclusion.
6. Subject willing and able to read, understand and sign an informed consent.

Exclusion Criteria:

1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
3. Diagnosis of aphasia or major cognitive decline
4. History of Deep brain stimulation (DBS)
5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
6. Active malignancy
7. Substance use at baseline.
8. 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
9. Serious suicidal ideation
10. Renal or liver insufficiency, electrolyte imbalances
11. Chronic heart failure with ejection fraction of 30 or less
12. HBOT for any reason prior to study enrolment
13. Chest pathology incompatible with pressure changes (including active asthma or COPD)
14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
15. An inability to perform an awake brain MRI
16. No evidence of vascular related lesions in the brain MRI
17. Active smoking
18. Participation in another study

Where this trial is running

Zrifin

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

Study contacts

• Principal investigator: Shai a Efrati, MD — Asaf-Harofhe MC
• Study coordinator: Shai a Efrati, MD

Conditions Post Stroke Depression; hyperbaric oxygen therapy