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Hyperbaric Oxygen Therapy for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment and Vascular Subcortical Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment and Vascular Subcortical Ischemia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assaf-Harofeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyperbaric oxygen therapy

Standard follow up

Arm Description

Hyperbaric oxygen therapy

Outcomes

Primary Outcome Measures

Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog)

Secondary Outcome Measures

Daily functioning, autonomy and quality of life
Safety of HBOT in patients with mci

Full Information

First Posted
March 11, 2014
Last Updated
October 1, 2014
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02085330
Brief Title
Hyperbaric Oxygen Therapy for Mild Cognitive Impairment
Official Title
Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment and Vascular Subcortical Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
Hyperbaric oxygen therapy
Arm Title
Standard follow up
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
100%, 2 ATA, 90 minutes
Primary Outcome Measure Information:
Title
Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Daily functioning, autonomy and quality of life
Time Frame
3 months
Title
Safety of HBOT in patients with mci
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shai Efrati, MD
Phone
972-549-212-866
Email
efratishai@013.net
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shai efrati, MD
Phone
972-549-212-866
Email
efratishai@013.net

12. IPD Sharing Statement

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Hyperbaric Oxygen Therapy for Mild Cognitive Impairment

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