NCT03447236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

February 18, 2018

Last Update Submit

September 15, 2019

Conditions

Mild Cognitive Impairment

Keywords

Older peopleCognitive trainingMCI

Outcome Measures

Primary Outcomes (1)

  • Change from baseline functional connectivity

    Based on correlation coefficient of FMRI signal between brain regions

    Through study completion, an average of 11 months

Secondary Outcomes (1)

  • Change from baseline cognitive function

    Through study completion, an average of 11 months

Study Arms (1)

Feuerstein Program

EXPERIMENTAL

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

Interventions

Feuerstein ProgramBEHAVIORAL

Mediated learning cognitive enhancement program

Feuerstein Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Related Publications (12)

  • Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.

    PMID: 14594456BACKGROUND

  • Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.

    PMID: 23124009BACKGROUND

  • Hostage CA, Choudhury KR, Murali Doraiswamy P, Petrella JR; Alzheimer's Disease Neuroimaging Initiative. Mapping the effect of the apolipoprotein E genotype on 4-year atrophy rates in an Alzheimer disease-related brain network. Radiology. 2014 Apr;271(1):211-9. doi: 10.1148/radiol.13131041. Epub 2013 Dec 12.

    PMID: 24475827BACKGROUND

  • Esposito R, Mosca A, Pieramico V, Cieri F, Cera N, Sensi SL. Characterization of resting state activity in MCI individuals. PeerJ. 2013 Aug 20;1:e135. doi: 10.7717/peerj.135. eCollection 2013.

    PMID: 24010015BACKGROUND

  • Deng Y, Liu K, Shi L, Lei Y, Liang P, Li K, Chu WC, Wang D; Alzheimer's Disease Neuroimaging Initiative. Identifying the Alteration Patterns of Brain Functional Connectivity in Progressive Mild Cognitive Impairment Patients: A Longitudinal Whole-Brain Voxel-Wise Degree Analysis. Front Aging Neurosci. 2016 Aug 17;8:195. doi: 10.3389/fnagi.2016.00195. eCollection 2016.

    PMID: 27582703BACKGROUND

  • Li Y, Wang X, Li Y, Sun Y, Sheng C, Li H, Li X, Yu Y, Chen G, Hu X, Jing B, Wang D, Li K, Jessen F, Xia M, Han Y. Abnormal Resting-State Functional Connectivity Strength in Mild Cognitive Impairment and Its Conversion to Alzheimer's Disease. Neural Plast. 2016;2016:4680972. doi: 10.1155/2016/4680972. Epub 2015 Dec 30.

    PMID: 26843991BACKGROUND

  • Meskaldji DE, Preti MG, Bolton TA, Montandon ML, Rodriguez C, Morgenthaler S, Giannakopoulos P, Haller S, Van De Ville D. Prediction of long-term memory scores in MCI based on resting-state fMRI. Neuroimage Clin. 2016 Oct 11;12:785-795. doi: 10.1016/j.nicl.2016.10.004. eCollection 2016.

    PMID: 27812505BACKGROUND

  • Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10.

    PMID: 24120430BACKGROUND

  • Eyre HA, Acevedo B, Yang H, Siddarth P, Van Dyk K, Ercoli L, Leaver AM, Cyr NS, Narr K, Baune BT, Khalsa DS, Lavretsky H. Changes in Neural Connectivity and Memory Following a Yoga Intervention for Older Adults: A Pilot Study. J Alzheimers Dis. 2016;52(2):673-84. doi: 10.3233/JAD-150653.

    PMID: 27060939BACKGROUND

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PMID: 25831962BACKGROUND

  • Karahanoglu FI, Van De Ville D. Transient brain activity disentangles fMRI resting-state dynamics in terms of spatially and temporally overlapping networks. Nat Commun. 2015 Jul 16;6:7751. doi: 10.1038/ncomms8751.

    PMID: 26178017BACKGROUND

  • Allan TW, Francis ST, Caballero-Gaudes C, Morris PG, Liddle EB, Liddle PF, Brookes MJ, Gowland PA. Functional Connectivity in MRI Is Driven by Spontaneous BOLD Events. PLoS One. 2015 Apr 29;10(4):e0124577. doi: 10.1371/journal.pone.0124577. eCollection 2015.

    PMID: 25922945BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Tzvi Dwolatzky, MD MBBCh

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Geriatrics

Study Record Dates

First Submitted

February 18, 2018

First Posted

February 27, 2018

Study Start

July 4, 2017

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)