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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperbaric oxygen therapy (HBOT) active treatment | Active Comparator | The HBOT protocol consists of 60 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes. |
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| Sham hyperbaric oxygen therapy (HBOT) Sham treatment | Sham Comparator | All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, each session includes breathing 21% oxygen by mask while in the same multiplace chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks, every 20 minutes The initial 1.2 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PSD symptoms | Depression severity will be evaluated by structured interview based on the HDRS-17 guided structural questioner (Hamilton Depression Rating Scale from 0-53 ,Levels of depression is categorized according to the following accepted criteria:
| Change from Baseline immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| depression | Beck depression inventory II. Each answer is scored on a scale value of 0 to 3 . The score ranges between 0 and 63, with higher scores indicating more severe depression symptoms. | Change from Baseline immediately after the intervention |
| Short form health survey (sf-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shai a Efrati, MD | Contact | 972549212866 | efratishai@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Shai a Efrati, MD | Asaf-Harofhe MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) | Recruiting | Zrifin | 70300 | Israel |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
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|
Quality of life questionnaire, scale of 0-100, higher score means better outcome |
| at baseline, 3 months, 6 months |
| psychological distress | The Brief Symptom Inventory-18 (BSI-18). self-report questionnaire which generates a summary scale, the global stress index (GSI), and three subscales: depression, anxiety, and somatization. Each item is rated on a 5-point scale, with distress ratings ranging from 0 (not at all) to 4 (extremely) . | Change from Baseline immediately after the intervention |
| health status | Changes will be measured by The Stroke Impact Scale (SIS). The SIS version 3.0 includes 59 items, An extra question on stroke recovery asks that the client rate on a scale from 0 - 100 how much the client feels that he/she has recovered from his/her stroke. | Change from Baseline immediately after the intervention |
| independent living skills | Changes will be measured by Instrumental Activities of Daily Living (IADL) Scale. There are eight domains of function measured with the Lawton IADL scale. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. | Change from Baseline immediately after the intervention |
| NeuroTrax | computerized cognitive evaluation battery. each outcome parameter will be normalized and fit to an IQ-like scale (mean=100, STD=15), according to the participants' age and education. | at baseline, 3 months |
| MoCA | Montreal Cognitive Assessment (MoCA). The maximum MoCA score is 30 points, with a 1-point scoring correction for individuals with 12 years of education or less. A score of 26 or above is considered normal and a score lower than 26 has been considered to be the optimal cutoff point for diagnosis of cognitive impairment. | Change from Baseline immediately after the intervention |
| CANTAB Cambridge Neuropsychological Test Automated Battery | computerized cognitive evaluation battery test, divided into 2 tasks: 1- Multitasking test (MTT)- attention, reaction time and executive functions, Multitasking test Incongruency cost - A higher incongruency cost indicates that the subjects takes longer to process conflicting information. 2-Paired associated learning (PAL)- visual memory and new learning, PAL Number of Patterns Reached (0-8), PAL Total Errors (Adjusted) (0-64), PAL Total Attempts(0-64). | at baseline, 3 months |
| MRI Imaging | At each of the evaluations, patients will undergo structural and functional MRI scanning. Images will be acquired on Vida 3 Tesla Scanner, configured with a 64-channel receiver head coils (Siemens Healthcare, Erlangen, Germany) at Shamir medical center radiology department. | Change from Baseline immediately after the intervention |
| fMRI Imaging | Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI). | Change from Baseline immediately after the intervention |
| Physical, Neurological and functional evaluation | A general physical and neurological evaluation will be done. NIHSS - The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS), will be used as part of the neurological evaluation to objectively quantify the impairment caused by the stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4 .For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. | Change from Baseline immediately after the intervention |
| electrical brain activity | Quantitative EEG (qEEG) including task related EEG analysis. EEG analysis for each state within subject and between subjects will include frequency analysis (peak frequency and relative power), oscillations (proportions of the different bands alpha, beta, theta, delta activities) and power spectra distribution. | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 1 | blood tests will include Inflammatory markers: IL-1 (IL-1β): pg/mL | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 2 | blood tests will include Inflammatory markers: IL-6: pg/mL | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 3 | blood tests will include Inflammatory markers: Tumor necrosis factor-alpha (TNF-α): pg/mL | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 4 | blood tests will include Inflammatory markers: hsCRP (high-sensitivity C-reactive protein): mg/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 5 | blood tests will include Inflammatory markers: Exosomes: particles/mL (by NTA) or µg protein/mL (by protein assay) | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 6 | blood tests will include Inflammatory markers: Serum VEGF: pg/mL | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 7 | blood tests will include Inflammatory markers: Testosterone (serum): ng/dL or nmol/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 8 | blood tests will include Inflammatory markers: Estradiol (E2, serum): pg/mL or pmol/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 9 | blood tests will include Inflammatory markers: DHEA-S (serum): µg/dL (commonly) or µmol/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 10 | blood tests will include Inflammatory markers: Progesterone (serum): ng/mL or nmol/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 11 | blood tests will include Inflammatory markers: Cortisol (serum): µg/dL or nmol/L | Change from Baseline immediately after the intervention |
| Inflammatory cytokines 12 | blood tests will include Inflammatory markers: Telomere length: kilobases (kb) or relative T/S ratio (qPCR, arbitrary units) | Change from Baseline immediately after the intervention |