NCT07423273

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Post-stroke depression (PSD) is a prevalent mental health complication, affecting approximately 33% of stroke survivors. Its occurrence not only hinders rehabilitation and recovery from motor and cognitive deficits post-stroke but also escalates the risk of subsequent neurovascular events. Both biological and psychological factors are instrumental in the onset of PSD. Ischemia plays a pivotal role in the development of long-term PSD due to its impact on specific brain regions, neurotransmitter systems, neural connectivity, inflammatory responses, and mitochondrial dysfunction. brain ischemia can instigate a protracted cycle of inflammation, levels and functions of neurotransmitters, impaired mitochondrial function, that directly impinges on the brain's ability to undergo neuroplastic changes. This relationship underscores the importance of targeting the cure of brain ischemia in therapeutic strategies for PSD. Managing the brain ischemia could potentially salvage neuroplasticity and mitigate the mental and cognitive decline associated with PSD. The new protocols of hyperbaric oxygen therapy (HBOT), using the hyperoxic-hypoxic paradox (HHP), is one of the first therapeutic intervention already in clinical use today for the specific goal of inducing regeneration of damaged brain tissue. Cumulative data from recent years provide convincing evidence that HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in post-stroke patients. Both neurological and cognitive functions were improved even years after the stroke. The observed restoration of neuronal activity in the metabolically dysfunctional stunned areas indicates that HBOT is a potent means of delivering sufficient oxygen needed for activation of neuroplasticty and restoration of impaired functions. HBOT was found to be effective in small clinical trials for patients suffering from post-stroke depression. In a meta-analysis done by Liang et al. the efficacy and safety of HBOT for PSD was evaluated. A total of 27 RCTs involving 2250 participants were identified. Patients in HBOT group had a higher response rate than patients in control group (response rate: 69.4% vs 51.2%, odds ratio \[OR\] = 2.51, 95% confidence interval \[CI\] \[1.83-3.43\], P = 0.000). HBOT significantly reduced Hamilton Depression (HAMD). The aim of the current study is to evaluate the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.

Conditions

• Post Stroke Depression

Interventions

Type	Name	Description
DEVICE	hyperbaric 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.

Timeline

• Start date: 2023-11-08
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2026-02-20
• Last updated: 2026-04-17

Locations

1 site across 1 country: Israel