Functional MRI Changes Resulting From the Feuerstein Program in Older People With Mild Cognitive Impairment (MCI)
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ClinicalTrials.gov Identifier: NCT03447236 |
Recruitment Status :
Completed
First Posted : February 27, 2018
Last Update Posted : September 17, 2019
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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 |
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Mild Cognitive Impairment | Behavioral: Feuerstein Program | Not Applicable |

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 |
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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.
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Behavioral: Feuerstein Program
Mediated learning cognitive enhancement program |
- 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
- Change from baseline cognitive function [ Time Frame: Through study completion, an average of 11 months ]Based on Neurotrax computerized neuropsychological assessment battery

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 60 and above.
- Hebrew speakers.
- Expressing willingness to participate in the research and deliberately signing a consent form.
- 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:
- A medical or functional condition that will not allow the subject to participate in the intervention program within the research period.
- Diagnosed subjects suffering from active depression, bipolar disorder or schizophrenia.
- Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
- Visual impairment that will not allow subjects to observe detailed information on a 32' screen from a distance of 1 meter.
- Hearing impairment that will not allow subjects to listen to instructions during assessment.
- Subjects whose MoCA Test's score is 17 and below or 27 and above.
- Subjects unable to undergo MRI assessments based on a standard questionnaire of eligibility for MRI excluding the use of metal and electronic implants.
- Subjects who will decide not to participate following a 10 minute MRI scan which will allow subjects to experience the procedure.
- The finding of a Random Space Occupying Lesion on MRI scan at initial anatomical assessment.

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
Israel | |
Rambam Health Care Campus | |
Haifa, Israel, 3109601 |
Principal Investigator: | Tzvi Dwolatzky, MD MBBCh | Rambam Health Care Campus |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Older people Cognitive training MCI |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |