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Hyperbaric Oxygen Therapy for Mild Cognitive Impairment

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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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
Mild Cognitive Impairment and Vascular Subcortical Ischemia Device: Hyperbaric oxygen therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy
Device: Hyperbaric oxygen therapy
100%, 2 ATA, 90 minutes
No Intervention: Standard follow up


Outcome Measures

Primary Outcome Measures :
  1. Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Daily functioning, autonomy and quality of life [ Time Frame: 3 months ]
  2. Safety of HBOT in patients with mci [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as suffering from Mild Cognitive Impairment by-National Institute on Aging Alzheimer Association criteria.
  • Patients diagnosed as suffering from MCI to be due to Vascular Subcortical Ischemia by subcortical vascular changes in MRI, according to the MRI protocol of the European multicenter leukoaraiosis and disability study protocol.
  • At least 1 of the following vascular risk factors arterial hypertension or known hypertension treated by blood pressure lowering medications, hypercholesterolemia.
  • The onset of the disease is slow and gradual
  • The course is continuously or step-like progressive for more than 1 year
  • Patients who are ambulatory
  • No other active neurological, systemic or psychiatric conditions that might be the primary cause of the current syndrome or significantly affect the current cognitive disorder.
  • No previous brain disorder except the current contingency of the cognitive disorder.
  • Balanced systemic psychiatric state for the past 3 months.

Exclusion Criteria:

  • Dynamic neurologic improvement or worsening during the last month
  • Had been treated with HBOT for any other reason prior to their inclusion
  • Have any other indication for HBOT
  • Chest pathology incompatible with pressure changes
  • Inner ear disease
  • Patients suffering from claustrophobia
  • Patients suffering from any active malignant disease
  • Inability to sign written informed consent.
  • Patients with cognitive changes which cannot be defined as Mild Cognitive Impairment by National Institute on Aging Alzheimer Association criteria and global CDR score.
  • Patients who do not have Vascular Subcortical Ischemia by the subcortical vascular changes in MRI according to the European multicenter leukoaraiosis and disability study protocol.
  • The onset of the disease is not slow and gradual.
  • The course is not continuously or step like progressive for more than 1 year.
  • Patients who are not ambulatory
  • There are other active neurological, systemic or psychiatric conditions that might be the primary cause of the current syndrome or significantly affect the current cognitive disorder.
  • Any previous brain disorder except the current contingency of the cognitive disorder.
  • Patients whose systemic psychiatric state is not balanced for the past 3 months.
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Shai Efrati, MD 972-549-212-866 efratishai@013.net

Locations
Israel
Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Shai efrati, MD    972-549-212-866    efratishai@013.net   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information

Responsible Party: Assaf Harofeh MC, Dr. Shai Efrati, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02085330     History of Changes
Other Study ID Numbers: 69/13
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Ischemia
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders