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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT02085330
First received: March 11, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily functioning, autonomy and quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Safety of HBOT in patients with mci [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy
Device: Hyperbaric oxygen therapy
100%, 2 ATA, 90 minutes
No Intervention: Standard follow up

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 11, 2014
Last Updated: March 11, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Ischemia
Cognition Disorders
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014