Hyperbaric oxygen therapy for persistent post-stroke depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: efratishai@outlook.com
• Phone: 972549212866

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting depression risk after an ischemic stroke

  This project will try to use machine learning on clinical and other patient data to predict which people hospitalized with an acute ischemic stroke will develop depression.

  Recruiting First Affiliated Hospital of Chongqing Medical University · Chongqing · NCT07294274

• Building physical capacity after chronic stroke

  This 12-week modified cardiac rehabilitation program will try to improve physical fitness and mood in people living with chronic stroke, including those with post-stroke depression.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07039305

• Effects of natural light on stroke recovery complications

  This study tests if using natural light during rehab can help stroke patients feel less depressed and tired as they recover.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Glostrup Municipality, Capital Region · NCT06922409

• Telephone/video behavioral activation to prevent depression after a first stroke in low-income older adults

  This project will test whether coaching-style behavioral activation delivered by trained lay counselors over phone or video can prevent depression in low-income older adults who recently had a first stroke and currently have mild or no depressive symptoms.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT06864715

• Zuranolone (allopregnanolone) for post-stroke depression

  This trial will test whether a 14-day course of oral zuranolone is safe, well tolerated, and can reduce moderate to severe depression in adults 21–65 who developed depression within a year after a stroke.

  Recruiting Phase 2 Duke University · Durham, North Carolina · NCT06759558

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.