Hyperbaric Oxygen Therapy for Mild Cognitive Impairment

October 1, 2014 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf-Harofeh Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 86 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily functioning, autonomy and quality of life
Time Frame: 3 months
3 months
Safety of HBOT in patients with mci
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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