An interventional study of Feuerstein Program in Mild Cognitive Impairment, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Prevention
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.
Introduction
In recent decades, with the increase in life expectancy, the number of older people and their relative rate within the population have risen dramatically. This trend led to increased rates of people suffering from a mild cognitive disorder and dementia in developed countries. Mild Neurocognitive Disorder or Mild Cognitive Impairment (MCI) is defined as a transition state between successful aging and a state of dementia. This state is characterized by cognitive impairment and a decline in memory skills while daily functioning is maintained.
Older people diagnosed with MCI are at increased risk of developing dementia, particularly Alzheimer's disease. This risk is ranked at about 12% every year.
Since this is a pre-dementia stage, great importance lies in finding methods that may prevent or at least decelerate the progress of MCI to dementia. Cognitive training is believed to be an appropriate intervention for preserving cognitive function.
The Feuerstein Program
This program is designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above (hereinafter "The Feuerstein Program"). The program is the initiative and brainchild of Professor Reuven Feuerstein - Israel Prize Laureate, founder and President of the Feuerstein Institute for the Enhancement of Learning Potential.
The program is based on the theories of Structural Cognitive Modifiability as well as on Mediated Learning Experience. For the needs of this program, the tools were suited to the unique characteristics and requirements of the older population.
The program is composed of a variety of tools (hereinafter: instrumental enrichment) that offer systematic activities intended to stimulate mental and cognitive development.
Instrumental enrichment is a set of tools dealing with required thinking skills to promote learning and thinking processes. The tasks of the various tools are free of educational content and they engage in pure learning and thinking processes. The tools are delivered through a special mediation approach, in which teachers and supervisors are trained in specialized courses.
Objectives of the Feuerstein Program
The main objective: to enhance the transformation (variability) capacity of a human being.
The sub-objectives:
The Learning Process
The instrumental enrichment tools are distributed to the participant as work sheets. The teacher creates a "mediating" dialogue between himself and the participants, thus enabling them to construct learning skills and essential thinking strategies. In addition, the teacher bridges the learning skills that were studied to the daily life of the older participant.
Products
The Intervention Focuses of the Instrumental Enrichment Tools that will be utilized in the Program
MRI imaging
The current study includes anatomical and functional MRI imaging in order to evaluate the relationship between cognitive changes and brain functional connectivity.
Research Objective
Examining the effects of the Feuerstein Program on brain functional connectivity as measured by MRI and cognitive function assessed by a computerized cognitive battery in subjects with MCI.
Research Hypothesis
The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity.
Methodology
An open-label single group interventional study.
Research Assessment Tools
The intervention
Phase 1:
15 participants will undergo the aforementioned assessments at baseline followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Phase 2:
15 participants will undergo the aforementioned assessments initially, followed by a waiting period of 15 weeks without intervention (baseline function). This will be followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Data Analysis The statistical analysis will be conducted as is customary in clinical research within the field.
Exclusion Criteria:
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
Change from baseline functional connectivity
Based on correlation coefficient of FMRI signal between brain regions
Time frame: Through study completion, an average of 11 months
Change from baseline cognitive function
Based on Neurotrax computerized neuropsychological assessment battery
Time frame: Through study completion, an average of 11 months
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rambam Health Care Campus