Hyperbaric Oxygen Therapy for Mild Cognitive Impairment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02085330|
Recruitment Status : Unknown
Verified October 2014 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : March 12, 2014
Last Update Posted : October 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment and Vascular Subcortical Ischemia||Device: Hyperbaric oxygen therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||February 2017|
Experimental: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy
Device: Hyperbaric oxygen therapy
100%, 2 ATA, 90 minutes
|No Intervention: Standard follow up|
- Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) [ Time Frame: 3 months ]
- Daily functioning, autonomy and quality of life [ Time Frame: 3 months ]
- Safety of HBOT in patients with mci [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085330
|Contact: Shai Efrati, MDfirstname.lastname@example.org|
|Assaf-Harofeh Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Shai efrati, MD 972-549-212-866 email@example.com|