We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Functional MRI Changes Resulting From the Feuerstein Program in Older People With Mild Cognitive Impairment (MCI)

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: NCT03447236
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : September 17, 2019
Adolf und Mary Mil-Stiftung
Helen Bader Foundation
Montreal Jewish Community Fund
Rochlin Family Foundation
Information provided by (Responsible Party):
Tzvi Dwolatzky, Rambam Health Care Campus

Brief Summary:

Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above. The program is an applied practicable program based on the theories of Structural Cognitive Modifiability as well as on a Mediated Learning Experience. The program takes into consideration the unique characteristics and requirements of the older population. The program is composed of a variety of cognitive tasks that offer systematic activities intended to stimulate mental and cognitive development.

Objective: To examine the influence of the Feuerstein Program on brain functional connectivity as measured by MRI assessments and cognitive function of participants suffering from Mild Cognitive Impairment (MCI).

Hypothesis: The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity.

Methods: Residents of retirement homes will be offered to participate in the study. Participants will undergo cognitive and MRI assessments prior to and following a period of cognitive intervention using the Feuerstein Instrumental Enrichment Program.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Feuerstein Program Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Evaluation of Changes in Brain Functional Connectivity Resulting From Cognitive Intervention by Means of the Feuerstein Instrumental Enrichment Program in Older People With Mild Cognitive Impairment (MCI)
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Arm Intervention/treatment
Experimental: Feuerstein Program
All subjects participating in the Feuerstein Program will be evaluated by anatomical and functional MRI as well as computerized cognitive assessment prior to and following intervention as outlined in the protocol.
Behavioral: Feuerstein Program
Mediated learning cognitive enhancement program

Primary Outcome Measures :
  1. Change from baseline functional connectivity [ Time Frame: Through study completion, an average of 11 months ]
    Based on correlation coefficient of FMRI signal between brain regions

Secondary Outcome Measures :
  1. Change from baseline cognitive function [ Time Frame: Through study completion, an average of 11 months ]
    Based on Neurotrax computerized neuropsychological assessment battery

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged 60 and above.
  2. Hebrew speakers.
  3. Expressing willingness to participate in the research and deliberately signing a consent form.
  4. A diagnosis of MCI exists according to accepted clinical criteria - the examinee's score in the MoCA Test is within the range of 18-26 (inclusive).

Exclusion Criteria:

  1. A medical or functional condition that will not allow the subject to participate in the intervention program within the research period.
  2. Diagnosed subjects suffering from active depression, bipolar disorder or schizophrenia.
  3. Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
  4. Visual impairment that will not allow subjects to observe detailed information on a 32' screen from a distance of 1 meter.
  5. Hearing impairment that will not allow subjects to listen to instructions during assessment.
  6. Subjects whose MoCA Test's score is 17 and below or 27 and above.
  7. Subjects unable to undergo MRI assessments based on a standard questionnaire of eligibility for MRI excluding the use of metal and electronic implants.
  8. Subjects who will decide not to participate following a 10 minute MRI scan which will allow subjects to experience the procedure.
  9. The finding of a Random Space Occupying Lesion on MRI scan at initial anatomical assessment.

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): NCT03447236

Layout table for location information
Rambam Health Care Campus
Haifa, Israel, 3109601
Sponsors and Collaborators
Rambam Health Care Campus
Adolf und Mary Mil-Stiftung
Helen Bader Foundation
Montreal Jewish Community Fund
Rochlin Family Foundation
Layout table for investigator information
Principal Investigator: Tzvi Dwolatzky, MD MBBCh Rambam Health Care Campus

Layout table for additonal information
Responsible Party: Tzvi Dwolatzky, Director Geriatrics, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03447236    
Other Study ID Numbers: 0580-16-RMB
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tzvi Dwolatzky, Rambam Health Care Campus:
Older people
Cognitive training
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders