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Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is about 15-20% of the population over the age of 65. The most common forms of dementia among the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of coexisting of AD and VD among the dementia patients, defined as mixed dementia.
Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also considered as a prodromal phase of both VD and AD. Its basic clinical features include: cognitive concern, reflecting a change in cognition, reported by the patient or informant (i.e., historical or observed evidence of decline over time), with objective evidence of impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as preservation of independence in functional abilities and not being demented (i.e., no significant impairment social or occupational functioning).
Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in plasma to a level sufficient to support tissues with minimal oxygen supply carried on by hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it seems that HBOT might be an efficient and clinically feasible method capable of increasing tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically vascular-lesioned areas during the post microvascular lesion phase.
This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Hyperbaric oxygen therapy |
|
| Standard follow up | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen therapy | Device | 100%, 2 ATA, 90 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Daily functioning, autonomy and quality of life | 3 months | |
| Safety of HBOT in patients with mci | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shai Efrati, MD | Contact | 972-549-212-866 | efratishai@013.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-Harofeh Medical Center | Recruiting | Ẕerifin | 70300 | Israel |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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